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Antihypertensive Treatment of Acute Cerebral Hemorrhage-II (ATACH-II)

Primary Purpose

Intracerebral Hemorrhage

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Intravenous nicardipine hydrochloride
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracerebral Hemorrhage focused on measuring Acute hypertensive response, intracerebral hemorrhage, blood pressure, outcome, nicardipine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 years or older
  • IV nicardipine can be initiated within 4.5 hours of symptom onset.
  • Clinical signs consistent with the diagnosis of stroke, including impairment of language, motor function, cognition, and/or gaze, vision, or neglect.
  • Total Glasgow Coma Scale (GCS) score (aggregate of verbal, eye, and motor response scores) of 5 or greater at time of emergency department (ED) arrival.
  • International normalized ratio (INR) value < 1.5
  • CT scan demonstrates intraparenchymal hematoma with manual hematoma volume measurement <60 cc.
  • For subjects randomized prior to IV antihypertensive administration: SBP greater than 180 mmHg* prior to IV antihypertensive treatment (this includes pre-hospital treatment) AND WITHOUT spontaneous SBP reduction to below 180 mmHg at the time of randomization OR
  • For subjects randomized after IV antihypertensive administration: SBP greater than 180 mmHg* prior to IV antihypertensive treatment (this includes pre-hospital treatment) AND WITHOUT SBP reduction to below 140 mmHg at the time of randomization.

  • Informed consent obtained by subject, legally authorized representative, or next of kin.

    • Notes: The unit "mmHg" stands for "millimeters of mercury", a standard way of measuring blood pressure. Patients with SBP < 180 mmHg should be monitored for 4.5 hours from symptom onset as their SBP may rise to eligible levels before the eligibility window closes.

Exclusion Criteria:

  • ICH is due to previously known neoplasms, arteriovenous malformation (AVM), or aneurysms.
  • Intracerebral hematoma considered to be related to trauma.
  • ICH located in infratentorial regions such as pons or cerebellum.
  • Intraventricular hemorrhage (IVH) associated with intraparenchymal hemorrhage and blood completely fills one lateral ventricle or more than half of both ventricles.
  • Patient to receive immediate surgical evacuation.
  • Current pregnancy, or parturition within previous 30 days, or active lactation.
  • Use of dabigatran within the last 48 hours**.
  • A platelet count less than 50,000 per microliter (µL or mm3)
  • Known sensitivity to nicardipine.
  • Pre-morbid disability requiring assistance in ambulation or activities of daily living.
  • Subject's living will precludes aggressive ICU management.

  • Subject is currently participating in another interventional clinical trial

    • Use of dabigatran was clarified through investigator presentations, educational materials, and clinical tools to include newer similar class medications (such as rivaroxaban, apixaban, and edoxaban) that were being developed and in various stages of approval across enrolling countries through the course of this trial, in the event that patients using these medications may have been encountered during screening.

Sites / Locations

  • UAB Comprehensive Stroke Center
  • Maricopa Medical Center
  • Mayo Clinic Pheonix
  • Banner University Medical Center - South Campus
  • Banner University Medical Center - University Campus
  • Community Regional Medical Center of Fresno
  • University of California San Diego
  • Long Beach Memorial Medical Center
  • Ronald Regan UCLA Medical Center
  • Hoag Memorial Hospital Presbyterian
  • Stanford University
  • Sutter Roseville Medical Center
  • UC Davis Medical Center
  • UCSF Medical Center
  • Good Samaritan Hospital
  • Santa Clara Valley Medical Center
  • Colorado Neurological Institute
  • Yale - New Haven Hospital
  • Christiana Hospital
  • University of Florida Gainesville
  • Baptist Medical Center Jacksonville
  • Mayo Clinic - Jacksonville
  • University of South Florida, Tampa General Hospital
  • Grady Memorial Hospital
  • Emory University Hospital Midtown
  • Emory University Hospital
  • Eastern Idaho Medical Consultants
  • Loyola University Medical Center
  • Advocate Christ Medical Center
  • OSF Saint Francis Medical Center
  • Southern Illinois University Memorial Medical Center
  • Lutheran Hospital Indiana
  • Parkview Hospital
  • Kansas University Medical Center
  • University of Kentucky
  • University of Louisville
  • West Jefferson Medical Center
  • Interim LSU Hospital
  • Tulane Medical Center
  • Ochsner Clinic Foundation
  • Louisiana State University Health Sciences Center, Shreveport
  • Maine Medical Center
  • Massachusetts General Hospital
  • Brigham & Women's Hospital
  • Boston Medical Center
  • Wayne State University - Detroit Receiving Hospital
  • Henry Ford Health System
  • Sinai-Grace Hospital
  • Allegiance Health
  • William Beaumont Hospital
  • Essentia Health St. Mary's Medical Center
  • Fairview Southdale Hospital
  • Hennepin County Medical Center
  • St. Cloud Hospital
  • Regions Hospital
  • University of Mississippi Medical Center
  • Saint Luke's Neuroscience Institute
  • Research Medical Center
  • Saint Louis University
  • Cooper University Hospital
  • St. Joseph's Regional Medical Center
  • New Jersey Neuroscience Institute, JFK Medical Center
  • Hackensack University Medical Center
  • University of New Mexico
  • New York City Health and Hospitals Corp. / Kings County Hospital
  • Mamoides Medical Center
  • Sister of Charity/Buffalo Mercy Hospital, Catholic Health System
  • UHS Wilson Medical Center
  • North Shore University Hospital
  • SUNY Downstate
  • Columbia University
  • Lincoln Medical and Mental Health Center
  • Rochester General Hospital
  • Strong Stroke Center
  • Mission Hospital
  • Guilford Neurologic Associates
  • Vidant Medical Center
  • Novant Clinical Research Institute/Forsyth Medical Center
  • Wake Forest Baptist Medical Center (Wake Forest School of Medicine)
  • Akron General Hospital
  • University Hospitals Case Medical Center
  • Ohio State University - Wexner Medical Center
  • University of Toledo Medical Center
  • Oklahoma University Health Sciences Center (OUHSC)
  • Providence Brain and Spine Institute
  • Abington Memorial Hospital
  • Lehigh Valley Health Network
  • Geisinger Medical Center
  • Penn State Univ/ Hershey Med Center
  • Hahnemann University Hospital
  • University of Pennsylvania
  • Thomas Jefferson University
  • Temple University
  • UPMC Presbyterian Hospital
  • UPMC-Mercy Hospital
  • Reading Hospital
  • Wellspan York Hospital
  • Rhode Island Hospital
  • Palmetto Health
  • Vanderbilt Stroke Center
  • Seton Medical Center Austin
  • St. David's Medical Center
  • University Medical Center Brackenridge
  • UT Southwestern - Parkland Hospital
  • Texas Tech University Health Sciences Center
  • Valley Baptist Medical Center
  • Memorial Herman - Texas Medical Center
  • Baylor College of Medicine - Ben Taub Community Hospital
  • Baylor College of Medicine - St. Luke's Episcopal Hospital
  • Methodist Hospital - The Neurological Institute
  • University of Texas Health Science Center at San Antonio
  • Intermountain Medical Center
  • Virginia Commonwealth University Medical Center
  • West Virginia University - Ruby Memorial Hospital
  • Medical College of Wisconsin
  • Aurora St. Luke's Medical Center
  • University of Alberta
  • Montreal Neurological Institute and Hospital
  • The Second Hospital of Hebei Medical University
  • The Second Hospital of Shanxi Medical University
  • Baotou Central Hospital
  • Beijing Tiantan Hospital
  • Peking University Third Hospital
  • Datong Third People's Hospital
  • The First Hospital of Shanxi Medical University
  • The First People's Hospital of Taizhou
  • Tianjin Fourth Central Hospital
  • Wuhan Brain Hospital
  • Renmin Hospital of Wuhan University
  • People's Hopital of Zhengzhou
  • Charité Universtity Medicine Berlin
  • University of Bonn
  • University Hospital Dresden
  • Clinic Frankfurt Hoechst
  • University Hospital Halle
  • University Hospital Heidelberg
  • University Hospital Leipzig
  • University Hospital Mannheim
  • University Hospital Meunster
  • University of Tubingen
  • Nagoya Medical Center
  • Nakamura Memorial Hospital
  • Saiseikai Yokohamashi Tobu Hospital
  • Saiseikai Kumamoto Hospital
  • Kyushu Medical Center
  • Gifu University Hospital
  • St. Marianna - Toyoko
  • St. Marianna University Hospital
  • Kobe City Medical Center General Hospital
  • Kawasaki Medical School
  • National Cerebral and Cardiovascular Center
  • Kohnan Hospital
  • Toranomon Hospital
  • Saiseikai Central Hospital - Tokyo
  • Keio University Hospital
  • Kyorin University
  • Seoul National University Bundang Hospital
  • Chonnam National University Hospital
  • Seoul National University Hospital
  • Kyung Hee University Hospital
  • Seoul National University Boramae Hospital
  • Changhua Christian Hospital
  • Kaohsiung Veterans General Hospital
  • Kaohsiung Medical University Hospital
  • Taichung Veterans General Hopital
  • China Medical University Hospital
  • National Cheng Kung University Hospital
  • National Taiwan University Hospital
  • Shin-Kong Wu Ho-Su Memorial Hospital
  • Tri-Service General Hospital
  • Taipei Veteran's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Standard SBP Reduction Arm

Intensive SBP Reduction Arm

Arm Description

Intravenous nicardipine hydrochloride will be used as necessary (pro re nata or "PRN") as the primary agent in lowering SBP. The goal for the standard BP reduction group will be to reduce and maintain SBP < 180 mmHg for 24 hours from randomization. 160 mmHg is the target SBP for this arm. For the standard group, SBP below the assigned treatment range is not artificially elevated to stay within the range if lower SBP occurs with nicardipine turned off (no fluid bolus given unless SBP falls below 110 mmHg with nicardipine off and there is risk for hypotension). Euvolemic fluid maintenance is encouraged for all patients according to their medical needs, which may differ.

Intravenous nicardipine hydrochloride will be used as necessary (pro re nata or "PRN") as the primary agent in lowering SBP. The goal for the intensive BP reduction group will be to reduce and maintain SBP < 140 mmHg for 24 hours from randomization. 125 mmHg is the target SBP for this arm. For the intensive group, SBP falling below 110 mmHg (lower limit of the assigned treatment range) with nicardipine off is treated with normal saline fluid bolus to prevent or remedy hypotension. Euvolemic fluid maintenance is encouraged for all patients according to their medical needs, which may differ.

Outcomes

Primary Outcome Measures

Death or Disability According to Modified Rankin Scale Score at 90 Days (3 Months) From Randomization
The primary outcome was death or disability, defined by modified Rankin scale (mRS) of 4-6 at 90 days following treatment. The modified Rankin Scale score ranges from 0, indicating no symptoms, to 6, indicating death. A score of 4 indicates moderately severe disability including the inability to walk or attend to one's own bodily needs. A score of 5 indicates severe disability; bedridden, incontinent, and requiring constant nursing care. To score a 3 or lower on the mRS, a person must at least be able to walk without the assistance of another person. We chose the mRS because of its high inter-observer reliability, superiority to other indices, and consistency with previous trials in patients with ICH. Reliability was further increased by use of a structured interview template and by requiring mRS assessors to pass a certification test. Persons conducting the 90-day mRS assessment were to be unaware of the treatment arm or clinical course of the patients they assessed.

Secondary Outcome Measures

Quality of Life at 90 Days Using EuroQol (EQ) Measures: EQ-5D (EuroQol Five Dimension), Consisting of Standardized EQ-5D-3L (EuroQol Five Dimension, Three-Level) Questionnaire and EQ VAS (EuroQol Visual Analog Scale) Scores
Standardized scales developed by the EuroQol Research Foundation were used as a secondary outcome measure in addition to the mRS scale score. The EQ-5D is a simple, standardized non-disease-specific instrument for describing and valuating health-related quality of life. The EQ-5D-3L questionnaire consists of 5 questions in 5 different domains and allows for responses from 1 (the best outcome) to 3 (the worst outcome) in each of five categories (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Total scores range from 5 to 15, with lower scores indicating better quality of life and a higher score indicating a worse quality of life. A second component of EuroQol outcome measurements is a printed 20 cm visual analogue scale (EQ VAS) that appears somewhat like a thermometer, on which a score from 0 (worst imaginable health state or death) to 100 (best imaginable health state) is marked by the patient (or, when necessary, their proxy) with the scale in view.
Hematoma Expansion (Number of Patients With Hematoma Expansion of 33% or Greater Between the Baseline and 24 +/- 6 Hours Head CTs, as Measured by the Central Reader for Patients With Readable Scans for Both Time Points Submitted by Data Lock.)
Hematoma expansion as determined by serial CT scans: Hematoma expansion was defined as an increase in the volume of intraparenchymal hemorrhage of 33% or greater as measured by a central imaging analyst who was was unaware of the treatment assignments, clinical findings, and time points of image acquisition. The area of the hematoma was delineated by image analysis software with the use of density thresholds on each slice, followed by manual correction. To ensure accuracy and consistency of the readings, images were coded randomly and independently of subject numbers and manual correction was also done without awareness of treatment assignments, clinical findings, or time points of image acquisition. This data point is defined as being present (hematoma expansion of 33% or more was calculated between the baseline scan hematoma volume and the 24 +/- 6 hours hematoma volume measures at data analysis), meaning that hematoma expansion as defined must have occurred or it was not counted.

Full Information

First Posted
August 4, 2010
Last Updated
March 13, 2017
Sponsor
University of Minnesota
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), Medical University of South Carolina, Johns Hopkins University, University of Michigan, Neurocritical Care Research Network, National Cerebral and Cardiovascular Center, Japan, Japan Cardiovascular Research Foundation, Beijing Tiantan Hospital, China Medical University Hospital, University Hospital Heidelberg, Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01176565
Brief Title
Antihypertensive Treatment of Acute Cerebral Hemorrhage-II
Acronym
ATACH-II
Official Title
Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH)-II: A Phase III Randomized Multicenter Clinical Trial of Blood Pressure Reduction for Hypertension in Acute Intracerebral Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
Planned interim analysis: no significant outcome differences between groups
Study Start Date
May 15, 2011 (Actual)
Primary Completion Date
December 21, 2015 (Actual)
Study Completion Date
March 8, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), Medical University of South Carolina, Johns Hopkins University, University of Michigan, Neurocritical Care Research Network, National Cerebral and Cardiovascular Center, Japan, Japan Cardiovascular Research Foundation, Beijing Tiantan Hospital, China Medical University Hospital, University Hospital Heidelberg, Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The specific aims of this study are to: Definitively determine the therapeutic benefit of the intensive treatment relative to the standard treatment in the proportion of patients with death and disability (mRS 4-6) at 3 months among subjects with ICH who are treated within 4.5 hours of symptom onset. Evaluate the therapeutic benefit of the intensive treatment relative to the standard treatment in the subjects' quality of life as measured by EuroQol at 3 months. Evaluate the therapeutic benefit of the intensive treatment relative to the standard treatment in the proportion of hematoma expansion (defined as increase from baseline hematoma volume of at least 33%) and in the change from baseline peri-hematoma volume at 24 hours on the serial computed tomographic (CT) scans. Assess the safety of the intensive treatment relative to the standard treatment in the proportion of subjects with treatment-related serious adverse events (SAEs) within 72 hours.
Detailed Description
The report from a National Institute of Neurological Disorders and Stroke Workshop on priorities for clinical research in intracerebral hemorrhage (ICH) in December 2003 recommended clinical trials for evaluation of blood pressure (BP) management in acute ICH as a leading priority. The Special Writing Group of the Stroke Council of the American Heart Association in 1999 and 2007 emphasized the need for clinical trials to ensure evidence-based treatment of acute hypertension in ICH. Consequently, we propose to conduct a five-year international, multicenter, open-labeled, randomized, controlled, Phase III trial to determine the efficacy of early, intensive antihypertensive treatment using intravenous nicardipine for acute hypertension in subjects with co-morbid hypertension and spontaneous supratentorial ICH. The primary hypothesis of this large, streamlined, focused trial is that the group treated with intensive BP reduction (systolic BP [SBP] of 140 mmHg or less - hereafter referred to as the intensive treatment) using intravenous nicardipine infusion for 24 hours reduces the proportion of death and disability at 3 months by 10% or greater compared with the group treated with the standard BP reduction (SBP of 180 mmHg or less - hereafter referred to as the standard treatment) among patients with ICH treated within 4.5 hours of symptom onset. The underlying mechanism for this expected beneficial effect of intensive treatment is mediated through reduction of the rate and magnitude of hematoma expansion observed in approximately 38% of patients with acute ICH. The trial will recruit a maximum of 1,280 subjects with ICH who meet the eligibility criteria. The primary outcome is the proportion of death and disability at 3 months defined by modified Rankin scale (mRS) score of 4 to 6. The proposed clinical trial is the natural extension of numerous case series, a subsequent pilot trial funded by the National Institutes of Health National Institute of Health (NIH), and a preliminary randomized controlled trial in this patient group funded by the Australian National Health and Medical Research Council, that have recently confirmed the safety and tolerability of both the regimen and goals of the antihypertensive treatment in acutely hypertensive patients with ICH proposed in the present trial. The proposed trial will have important public health implications by providing necessary information regarding the efficacy and safety of antihypertensive treatment of acute hypertension observed in up to 75% of the subjects with ICH. BP treatment represents a strategy that can be made widely available without the need of specialized equipment and personnel and therefore can make a major impact upon outcome in patients with ICH. Substantial reduction in morbidity and mortality appears possible if the estimates of treatment effect sizes from current pilot trials are accurate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracerebral Hemorrhage
Keywords
Acute hypertensive response, intracerebral hemorrhage, blood pressure, outcome, nicardipine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Eligible patients are randomized 1:1 via computer-generated treatment assignment within 4.5 hours of neurological symptom onset to either standard or intensive SBP management using intravenous nicardipine hydrochloride as the primary BP control agent through 24 hours from randomization. Enrolled patients from both treatment arms are otherwise treated similarly after 24 hours, according to their medical needs. Standards of care management for spontaneous intracerebral hemorrhage published in the 2010 American Heart Association guidelines are incorporated in to the study protocol. All enrolled patients are followed through 90 days (± 14 days per protocol window; up to ± 30 days data is used) unless death or withdrawal occurs sooner. Primary analysis based on intent-to-treat (ITT) principles.
Masking
InvestigatorOutcomes Assessor
Masking Description
The trial intervention is conducted open-label to avoid concealing clinically necessary patient blood pressure and intravenous drug administration information. Clinical data including SBP values are primarily taken from entries recorded in to the patient's official medical record by hospital staff and are independently monitor-verified. Assessors for the primary outcome (mRS) at 90 days are are unaware of the treatment assignment or in-hospital clinical course of the subjects assessed. De-identified imaging studies are coded independently of subject number so the central imaging reader is unaware of the treatment assignment, clinical findings, or time points of image acquisition for data recorded from imaging. The study (lead) principal investigator and leadership committee members are unable to associate the treatment assignment of subjects to their outcomes or adverse events for purposes of trial decision-making. Adverse events are adjudicated by an independent oversight committee.
Allocation
Randomized
Enrollment
1000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard SBP Reduction Arm
Arm Type
Active Comparator
Arm Description
Intravenous nicardipine hydrochloride will be used as necessary (pro re nata or "PRN") as the primary agent in lowering SBP. The goal for the standard BP reduction group will be to reduce and maintain SBP < 180 mmHg for 24 hours from randomization. 160 mmHg is the target SBP for this arm. For the standard group, SBP below the assigned treatment range is not artificially elevated to stay within the range if lower SBP occurs with nicardipine turned off (no fluid bolus given unless SBP falls below 110 mmHg with nicardipine off and there is risk for hypotension). Euvolemic fluid maintenance is encouraged for all patients according to their medical needs, which may differ.
Arm Title
Intensive SBP Reduction Arm
Arm Type
Active Comparator
Arm Description
Intravenous nicardipine hydrochloride will be used as necessary (pro re nata or "PRN") as the primary agent in lowering SBP. The goal for the intensive BP reduction group will be to reduce and maintain SBP < 140 mmHg for 24 hours from randomization. 125 mmHg is the target SBP for this arm. For the intensive group, SBP falling below 110 mmHg (lower limit of the assigned treatment range) with nicardipine off is treated with normal saline fluid bolus to prevent or remedy hypotension. Euvolemic fluid maintenance is encouraged for all patients according to their medical needs, which may differ.
Intervention Type
Drug
Intervention Name(s)
Intravenous nicardipine hydrochloride
Other Intervention Name(s)
Cardene® I.V., Nicardipine HCl injection, nicardipine hydrochloride injection, nicardipine IV, nicardipine, nicardipine hydrochloride
Intervention Description
IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached. If SBP is above the target SBP despite infusion of the maximum nicardipine dose for 30 minutes, a second agent may be used (Labetalol 5-20 mg IV bolus every 15 min; diltiazem/urapidil in countries without labetalol) for another hour. Nicardipine infusion is decreased incrementally or is stopped if SBP falls below the desired treatment range. Fluid bolus for SBP still falling below 110 mmHG (millimeters of mercury) with nicardipine off is given to prevent organ hypoperfusion. Vasopressor agents are not used unless symptoms related to or possibly exacerbated by hypoperfusion are present.
Primary Outcome Measure Information:
Title
Death or Disability According to Modified Rankin Scale Score at 90 Days (3 Months) From Randomization
Description
The primary outcome was death or disability, defined by modified Rankin scale (mRS) of 4-6 at 90 days following treatment. The modified Rankin Scale score ranges from 0, indicating no symptoms, to 6, indicating death. A score of 4 indicates moderately severe disability including the inability to walk or attend to one's own bodily needs. A score of 5 indicates severe disability; bedridden, incontinent, and requiring constant nursing care. To score a 3 or lower on the mRS, a person must at least be able to walk without the assistance of another person. We chose the mRS because of its high inter-observer reliability, superiority to other indices, and consistency with previous trials in patients with ICH. Reliability was further increased by use of a structured interview template and by requiring mRS assessors to pass a certification test. Persons conducting the 90-day mRS assessment were to be unaware of the treatment arm or clinical course of the patients they assessed.
Time Frame
90 days (± 14 days per protocol window; up to ± 30 days data is used) from randomization
Secondary Outcome Measure Information:
Title
Quality of Life at 90 Days Using EuroQol (EQ) Measures: EQ-5D (EuroQol Five Dimension), Consisting of Standardized EQ-5D-3L (EuroQol Five Dimension, Three-Level) Questionnaire and EQ VAS (EuroQol Visual Analog Scale) Scores
Description
Standardized scales developed by the EuroQol Research Foundation were used as a secondary outcome measure in addition to the mRS scale score. The EQ-5D is a simple, standardized non-disease-specific instrument for describing and valuating health-related quality of life. The EQ-5D-3L questionnaire consists of 5 questions in 5 different domains and allows for responses from 1 (the best outcome) to 3 (the worst outcome) in each of five categories (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Total scores range from 5 to 15, with lower scores indicating better quality of life and a higher score indicating a worse quality of life. A second component of EuroQol outcome measurements is a printed 20 cm visual analogue scale (EQ VAS) that appears somewhat like a thermometer, on which a score from 0 (worst imaginable health state or death) to 100 (best imaginable health state) is marked by the patient (or, when necessary, their proxy) with the scale in view.
Time Frame
90 days (± 14 days per protocol window; up to ± 30 days data is used) from randomization
Title
Hematoma Expansion (Number of Patients With Hematoma Expansion of 33% or Greater Between the Baseline and 24 +/- 6 Hours Head CTs, as Measured by the Central Reader for Patients With Readable Scans for Both Time Points Submitted by Data Lock.)
Description
Hematoma expansion as determined by serial CT scans: Hematoma expansion was defined as an increase in the volume of intraparenchymal hemorrhage of 33% or greater as measured by a central imaging analyst who was was unaware of the treatment assignments, clinical findings, and time points of image acquisition. The area of the hematoma was delineated by image analysis software with the use of density thresholds on each slice, followed by manual correction. To ensure accuracy and consistency of the readings, images were coded randomly and independently of subject numbers and manual correction was also done without awareness of treatment assignments, clinical findings, or time points of image acquisition. This data point is defined as being present (hematoma expansion of 33% or more was calculated between the baseline scan hematoma volume and the 24 +/- 6 hours hematoma volume measures at data analysis), meaning that hematoma expansion as defined must have occurred or it was not counted.
Time Frame
From the baseline head CT to the 24 +/- 6 hours from randomization head CT
Other Pre-specified Outcome Measures:
Title
Neurological Deterioration Within 24 Hours, Defined by a Decrease of 2 or More Points on the GCS Score or an Increase of 4 or More Points on the NIHSS Score From Baseline, Not Related to Sedation or Hypnotic-agent Use and Sustained for at Least 8 Hours.
Description
Neurologic deterioration was measured using two scales. The Glasgow Coma Scale (GCS) score measures of level of consciousness in eye, motor, and verbal components. At least one point is given in each category. The scale ranges from 3 to 15, with 3 indicating deep unconsciousness and 15 indicating consciousness is not impaired. The National Institutes of Health Stroke Scale (NIHSS) quantifies neurologic deficits in 11 categories. Level of consciousness, horizontal eye movement, visual fields, facial palsy, movement in each limb, sensation, language & speech, and extinction or inattention on one side of the body are tested. Scores range from 0 to 42, with 0 indicating normal function and higher scores indicating greater deficit severity. Neurological status was checked per ICU standards through 24 hours, recommended as hourly GCS and full assessment every 2 hours. NIHSS assessment at baseline and 24 +/- 3 hours was pre-specified. Assessments were added for suspected neurological change.
Time Frame
From randomization through the 24-hour treatment period
Title
Hypotension Within 72 Hours
Description
Hypotension (abnormally low blood pressure) was the most likely adverse event that could be associated with the study treatment, and is the primary basis (risk) on which neurological deterioration or other untoward effects of the study treatment could occur. It is therefore examined as a numerically-measured occurrence in addition to monitoring patients closely for neurological deterioration or other symptoms. Hypotension, when named as an adverse event, was defined as the syndrome of low blood pressure with SBP < 85 mmHg. Instances of hypotension were to be avoided through close monitoring, and administration of fluid bolus for SBP < 110 mmHg. If hypotension did occur, it was to be reversed as quickly as possible through discontinuation of intravenous nicardipine and intravenous fluid administration, which can be accomplished readily in a variety of settings where patients with intracerebral hemorrhage are routinely housed during early hospitalization.
Time Frame
From randomization through 72 hours from randomization
Title
Treatment-related Serious Adverse Event Within 72 Hours of Randomization
Description
Adverse events (AEs) and serious adverse events (SAEs) were assessed by the site investigators for all patients, including for their potential relatedness to the study treatment. An Independent Oversight Committee (IOC) reviewed and adjudicated all adverse event data. The 72-hours-from-randomization time window was considered the most likely time frame during which treatment-related adverse events or serious adverse events would be observed. Terminology from the Medical Dictionary for Regulatory Activities (MedDRA) and severity criteria from the Common Terminology Criteria for Adverse Events (CTCAE v. 4.03) were used as a basis for reporting adverse events. Serious adverse events are defined as being fatal, life-threatening, resulting in hospitalization or prolonged hospitalization, resulting in disability or congenital anomaly, or requiring intervention to prevent permanent impairment or damage and were required to be reported promptly.
Time Frame
From randomization through 72 hours (3 days)
Title
Any Serious Adverse Event Within the 90-day Study Period
Description
The complete count of all subjects who experienced any serious adverse events throughout their participation in the trial was included in this tabulation. Adverse events (AEs) and serious adverse events (SAEs) were assessed by the site investigators for all patients. Potential relatedness to the study treatment was a required reporting element for all adverse events but was not considered in this count. Terminology from the Medical Dictionary for Regulatory Activities (MedDRA) and severity criteria from the Common Terminology Criteria for Adverse Events (CTCAE v. 4.03) were used as a basis for reporting adverse events. Serious adverse events are defined as being fatal, life-threatening, resulting in hospitalization or prolonged hospitalization, resulting in disability or congenital anomaly, or requiring intervention to prevent permanent impairment or damage and were required to be reported promptly. An Independent Oversight Committee (IOC) reviewed and adjudicated adverse event data.
Time Frame
From randomization through the 90 day visit (90 ± 14 days per protocol window; up to ± 30 days data is used) or until known death, withdrawal, or loss to follow-up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years or older IV nicardipine can be initiated within 4.5 hours of symptom onset. Clinical signs consistent with the diagnosis of stroke, including impairment of language, motor function, cognition, and/or gaze, vision, or neglect. Total Glasgow Coma Scale (GCS) score (aggregate of verbal, eye, and motor response scores) of 5 or greater at time of emergency department (ED) arrival. International normalized ratio (INR) value < 1.5 CT scan demonstrates intraparenchymal hematoma with manual hematoma volume measurement <60 cc. For subjects randomized prior to IV antihypertensive administration: SBP greater than 180 mmHg* prior to IV antihypertensive treatment (this includes pre-hospital treatment) AND WITHOUT spontaneous SBP reduction to below 180 mmHg at the time of randomization OR For subjects randomized after IV antihypertensive administration: SBP greater than 180 mmHg* prior to IV antihypertensive treatment (this includes pre-hospital treatment) AND WITHOUT SBP reduction to below 140 mmHg at the time of randomization. Informed consent obtained by subject, legally authorized representative, or next of kin. Notes: The unit "mmHg" stands for "millimeters of mercury", a standard way of measuring blood pressure. Patients with SBP < 180 mmHg should be monitored for 4.5 hours from symptom onset as their SBP may rise to eligible levels before the eligibility window closes. Exclusion Criteria: ICH is due to previously known neoplasms, arteriovenous malformation (AVM), or aneurysms. Intracerebral hematoma considered to be related to trauma. ICH located in infratentorial regions such as pons or cerebellum. Intraventricular hemorrhage (IVH) associated with intraparenchymal hemorrhage and blood completely fills one lateral ventricle or more than half of both ventricles. Patient to receive immediate surgical evacuation. Current pregnancy, or parturition within previous 30 days, or active lactation. Use of dabigatran within the last 48 hours**. A platelet count less than 50,000 per microliter (µL or mm3) Known sensitivity to nicardipine. Pre-morbid disability requiring assistance in ambulation or activities of daily living. Subject's living will precludes aggressive ICU management. Subject is currently participating in another interventional clinical trial Use of dabigatran was clarified through investigator presentations, educational materials, and clinical tools to include newer similar class medications (such as rivaroxaban, apixaban, and edoxaban) that were being developed and in various stages of approval across enrolling countries through the course of this trial, in the event that patients using these medications may have been encountered during screening.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adnan I Qureshi, MD
Organizational Affiliation
University of Minnesota
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yuko Y Palesch, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Adnan I Qureshi, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yuko Y Palesch, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAB Comprehensive Stroke Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
Maricopa Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85008
Country
United States
Facility Name
Mayo Clinic Pheonix
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Banner University Medical Center - South Campus
City
Tuscon
State/Province
Arizona
ZIP/Postal Code
85713
Country
United States
Facility Name
Banner University Medical Center - University Campus
City
Tuscon
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Community Regional Medical Center of Fresno
City
Fresno
State/Province
California
ZIP/Postal Code
93721
Country
United States
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Long Beach Memorial Medical Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Ronald Regan UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-9574
Country
United States
Facility Name
Hoag Memorial Hospital Presbyterian
City
Newport Beach
State/Province
California
ZIP/Postal Code
92658
Country
United States
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Sutter Roseville Medical Center
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
UCSF Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Good Samaritan Hospital
City
San Jose
State/Province
California
ZIP/Postal Code
95124
Country
United States
Facility Name
Santa Clara Valley Medical Center
City
Santa Clara
State/Province
California
ZIP/Postal Code
95138
Country
United States
Facility Name
Colorado Neurological Institute
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Yale - New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Christiana Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
University of Florida Gainesville
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Facility Name
Baptist Medical Center Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Mayo Clinic - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
University of South Florida, Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Grady Memorial Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Emory University Hospital Midtown
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Eastern Idaho Medical Consultants
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Advocate Christ Medical Center
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
OSF Saint Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Southern Illinois University Memorial Medical Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62794-9643
Country
United States
Facility Name
Lutheran Hospital Indiana
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Parkview Hospital
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46805
Country
United States
Facility Name
Kansas University Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0296
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40292
Country
United States
Facility Name
West Jefferson Medical Center
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Interim LSU Hospital
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Tulane Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Louisiana State University Health Sciences Center, Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Maine Medical Center
City
South Portland
State/Province
Maine
ZIP/Postal Code
04106
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Wayne State University - Detroit Receiving Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Sinai-Grace Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48235
Country
United States
Facility Name
Allegiance Health
City
Jackson
State/Province
Michigan
ZIP/Postal Code
49201
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Essentia Health St. Mary's Medical Center
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Fairview Southdale Hospital
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
St. Cloud Hospital
City
St. Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
Facility Name
Regions Hospital
City
St.Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Saint Luke's Neuroscience Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Research Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
St. Joseph's Regional Medical Center
City
Clifton
State/Province
New Jersey
ZIP/Postal Code
07012
Country
United States
Facility Name
New Jersey Neuroscience Institute, JFK Medical Center
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08818
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
New York City Health and Hospitals Corp. / Kings County Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Mamoides Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States
Facility Name
Sister of Charity/Buffalo Mercy Hospital, Catholic Health System
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States
Facility Name
UHS Wilson Medical Center
City
Johnson City
State/Province
New York
ZIP/Postal Code
13790
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
SUNY Downstate
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Lincoln Medical and Mental Health Center
City
New York
State/Province
New York
ZIP/Postal Code
10451
Country
United States
Facility Name
Rochester General Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14621
Country
United States
Facility Name
Strong Stroke Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Mission Hospital
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801-4601
Country
United States
Facility Name
Guilford Neurologic Associates
City
Greenboro
State/Province
North Carolina
ZIP/Postal Code
27405
Country
United States
Facility Name
Vidant Medical Center
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Novant Clinical Research Institute/Forsyth Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Wake Forest Baptist Medical Center (Wake Forest School of Medicine)
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Akron General Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44307
Country
United States
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Ohio State University - Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Toledo Medical Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Oklahoma University Health Sciences Center (OUHSC)
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Providence Brain and Spine Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Lehigh Valley Health Network
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Penn State Univ/ Hershey Med Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Hahnemann University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
UPMC Presbyterian Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
UPMC-Mercy Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15219
Country
United States
Facility Name
Reading Hospital
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Wellspan York Hospital
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17403
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Palmetto Health
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Vanderbilt Stroke Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Seton Medical Center Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
St. David's Medical Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
University Medical Center Brackenridge
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
UT Southwestern - Parkland Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Texas Tech University Health Sciences Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79430
Country
United States
Facility Name
Valley Baptist Medical Center
City
Harlingen
State/Province
Texas
ZIP/Postal Code
78550
Country
United States
Facility Name
Memorial Herman - Texas Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Baylor College of Medicine - Ben Taub Community Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Baylor College of Medicine - St. Luke's Episcopal Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Methodist Hospital - The Neurological Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Virginia Commonwealth University Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0631
Country
United States
Facility Name
West Virginia University - Ruby Memorial Hospital
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwakee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Aurora St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
2E3.27WMC
Country
Canada
Facility Name
Montreal Neurological Institute and Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada
Facility Name
The Second Hospital of Hebei Medical University
City
Shijiazhuang City
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Facility Name
The Second Hospital of Shanxi Medical University
City
Taiyuan City
State/Province
Shanxi
ZIP/Postal Code
030001
Country
China
Facility Name
Baotou Central Hospital
City
Baotou
Country
China
Facility Name
Beijing Tiantan Hospital
City
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Datong Third People's Hospital
City
Datong
Country
China
Facility Name
The First Hospital of Shanxi Medical University
City
Taiyuan City
ZIP/Postal Code
030001
Country
China
Facility Name
The First People's Hospital of Taizhou
City
Taizhou City
ZIP/Postal Code
318020
Country
China
Facility Name
Tianjin Fourth Central Hospital
City
Tianjin
ZIP/Postal Code
300140
Country
China
Facility Name
Wuhan Brain Hospital
City
Wuhan
ZIP/Postal Code
430019
Country
China
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
ZIP/Postal Code
430060
Country
China
Facility Name
People's Hopital of Zhengzhou
City
Zhengzhou
ZIP/Postal Code
450003
Country
China
Facility Name
Charité Universtity Medicine Berlin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
University of Bonn
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
University Hospital Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Clinic Frankfurt Hoechst
City
Frankfurt
ZIP/Postal Code
65929
Country
Germany
Facility Name
University Hospital Halle
City
Halle (Saale)
ZIP/Postal Code
06120
Country
Germany
Facility Name
University Hospital Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
University Hospital Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
University Hospital Mannheim
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
University Hospital Meunster
City
Munster
ZIP/Postal Code
48129
Country
Germany
Facility Name
University of Tubingen
City
Tubingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Nagoya Medical Center
City
Nagoya City
State/Province
Aichi
ZIP/Postal Code
460-0001
Country
Japan
Facility Name
Nakamura Memorial Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8570
Country
Japan
Facility Name
Saiseikai Yokohamashi Tobu Hospital
City
Kanagawa
State/Province
Kanagowa
ZIP/Postal Code
230-8765
Country
Japan
Facility Name
Saiseikai Kumamoto Hospital
City
Kumamoto City
State/Province
Kumamoto
ZIP/Postal Code
861-4193
Country
Japan
Facility Name
Kyushu Medical Center
City
Fukuoka
ZIP/Postal Code
810-8563
Country
Japan
Facility Name
Gifu University Hospital
City
Gifu
ZIP/Postal Code
501-1194
Country
Japan
Facility Name
St. Marianna - Toyoko
City
Kawasaki
ZIP/Postal Code
211-0063
Country
Japan
Facility Name
St. Marianna University Hospital
City
Kawasaki
ZIP/Postal Code
216-8511
Country
Japan
Facility Name
Kobe City Medical Center General Hospital
City
Kobe City
Country
Japan
Facility Name
Kawasaki Medical School
City
Okayama
ZIP/Postal Code
701-0192
Country
Japan
Facility Name
National Cerebral and Cardiovascular Center
City
Osaka
ZIP/Postal Code
565-8565
Country
Japan
Facility Name
Kohnan Hospital
City
Sendai
Country
Japan
Facility Name
Toranomon Hospital
City
Tokyo
ZIP/Postal Code
105-8470
Country
Japan
Facility Name
Saiseikai Central Hospital - Tokyo
City
Tokyo
ZIP/Postal Code
108-0073
Country
Japan
Facility Name
Keio University Hospital
City
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Kyorin University
City
Tokyo
Country
Japan
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
ZIP/Postal Code
501-757
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Kyung Hee University Hospital
City
Seoul
ZIP/Postal Code
130-702
Country
Korea, Republic of
Facility Name
Seoul National University Boramae Hospital
City
Seoul
ZIP/Postal Code
156-707
Country
Korea, Republic of
Facility Name
Changhua Christian Hospital
City
Changhua
Country
Taiwan
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung City
Country
Taiwan
Facility Name
Kaohsiung Medical University Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Taichung Veterans General Hopital
City
Taichung City
ZIP/Postal Code
407
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Shin-Kong Wu Ho-Su Memorial Hospital
City
Taipei
ZIP/Postal Code
111
Country
Taiwan
Facility Name
Tri-Service General Hospital
City
Taipei
ZIP/Postal Code
114
Country
Taiwan
Facility Name
Taipei Veteran's Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
A public use data set from the study database will be made available. A process for sharing subject head imaging studies that may be associated with the data set is under evaluation.
Citations:
PubMed Identifier
20457956
Citation
Qureshi AI, Palesch YY, Martin R, Novitzke J, Cruz-Flores S, Ehtisham A, Ezzeddine MA, Goldstein JN, Hussein HM, Suri MF, Tariq N; Antihypertensive Treatment of Acute Cerebral Hemorrhage Study Investigators. Effect of systolic blood pressure reduction on hematoma expansion, perihematomal edema, and 3-month outcome among patients with intracerebral hemorrhage: results from the antihypertensive treatment of acute cerebral hemorrhage study. Arch Neurol. 2010 May;67(5):570-6. doi: 10.1001/archneurol.2010.61.
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PubMed Identifier
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Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH) investigators. Antihypertensive treatment of acute cerebral hemorrhage. Crit Care Med. 2010 Feb;38(2):637-48. doi: 10.1097/CCM.0b013e3181b9e1a5.
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18606927
Citation
Qureshi AI. Acute hypertensive response in patients with stroke: pathophysiology and management. Circulation. 2008 Jul 8;118(2):176-87. doi: 10.1161/CIRCULATIONAHA.107.723874. No abstract available.
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PubMed Identifier
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Citation
Qureshi AI. Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH): rationale and design. Neurocrit Care. 2007;6(1):56-66. doi: 10.1385/ncc:6:1:56.
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Qureshi AI, Palesch YY. Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH) II: design, methods, and rationale. Neurocrit Care. 2011 Dec;15(3):559-76. doi: 10.1007/s12028-011-9538-3.
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PubMed Identifier
22560810
Citation
Qureshi AI, Palesch YY, Martin R, Novitzke J, Cruz Flores S, Ehtisham A, Goldstein JN, Kirmani JF, Hussein HM, Suri MF, Tariq N; Antihypertensive Treatment of Acute Cerebral Hemorrhage Investigators. Systolic blood pressure reduction and risk of acute renal injury in patients with intracerebral hemorrhage. Am J Med. 2012 Jul;125(7):718.e1-6. doi: 10.1016/j.amjmed.2011.09.031. Epub 2012 May 4.
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PubMed Identifier
25132910
Citation
Qureshi AI, Palesch YY, Martin R, Toyoda K, Yamamoto H, Wang Y, Wang Y, Hsu CY, Yoon BW, Steiner T, Butcher K, Hanley DF, Suarez JI. Interpretation and Implementation of Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial (INTERACT II). J Vasc Interv Neurol. 2014 Jun;7(2):34-40. No abstract available.
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PubMed Identifier
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Citation
Qureshi AI, Palesch YY, Barsan WG, Hanley DF, Hsu CY, Martin RL, Moy CS, Silbergleit R, Steiner T, Suarez JI, Toyoda K, Wang Y, Yamamoto H, Yoon BW; ATACH-2 Trial Investigators and the Neurological Emergency Treatment Trials Network. Intensive Blood-Pressure Lowering in Patients with Acute Cerebral Hemorrhage. N Engl J Med. 2016 Sep 15;375(11):1033-43. doi: 10.1056/NEJMoa1603460. Epub 2016 Jun 8.
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PubMed Identifier
35513751
Citation
Qureshi AI, Huang W, Hanley DF, Hsu CY, Martin RH, Malhotra K, Steiner T, Suarez JI, Yamamoto H, Toyoda K. Early Hyperchloremia is Independently Associated with Death or Disability in Patients with Intracerebral Hemorrhage. Neurocrit Care. 2022 Oct;37(2):487-496. doi: 10.1007/s12028-022-01514-2. Epub 2022 May 5.
Results Reference
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PubMed Identifier
35400202
Citation
Tanaka K, Koga M, Fukuda-Doi M, Qureshi AI, Yamamoto H, Miwa K, Ihara M, Toyoda K; ATACH-2 Trial Investigators. Temporal Trajectory of Systolic Blood Pressure and Outcomes in Acute Intracerebral Hemorrhage: ATACH-2 Trial Cohort. Stroke. 2022 Jun;53(6):1854-1862. doi: 10.1161/STROKEAHA.121.037186. Epub 2022 Apr 11.
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derived
PubMed Identifier
35022304
Citation
Tsukita K, Sakamaki-Tsukita H, Takahashi R. Long-term Effect of Regular Physical Activity and Exercise Habits in Patients With Early Parkinson Disease. Neurology. 2022 Feb 22;98(8):e859-e871. doi: 10.1212/WNL.0000000000013218. Epub 2022 Jan 12.
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derived
PubMed Identifier
34937780
Citation
Magid-Bernstein JR, Li Y, Cho SM, Piran PJ, Roh DJ, Gupta A, Shoamanesh A, Merkler A, Zhang C, Avadhani R, Montano N, Iadecola C, Falcone GJ, Sheth KN, Qureshi AI, Rosand J, Goldstein J, Awad I, Hanley DF, Kamel H, Ziai WC, Murthy SB. Cerebral Microbleeds and Acute Hematoma Characteristics in the ATACH-2 and MISTIE III Trials. Neurology. 2022 Mar 8;98(10):e1013-e1020. doi: 10.1212/WNL.0000000000013247. Epub 2021 Dec 22.
Results Reference
derived
PubMed Identifier
34844422
Citation
Qureshi AI, Huang W, Lobanova I, Chandrasekaran PN, Hanley DF, Hsu CY, Martin RH, Steiner T, Suarez JI, Yamamoto H, Toyoda K. Effect of Moderate and Severe Persistent Hyperglycemia on Outcomes in Patients With Intracerebral Hemorrhage. Stroke. 2022 Apr;53(4):1226-1234. doi: 10.1161/STROKEAHA.121.034928. Epub 2021 Nov 30.
Results Reference
derived
PubMed Identifier
34387101
Citation
Miwa K, Koga M, Fukuda-Doi M, Yamamoto H, Tanaka K, Yoshimura S, Ihara M, Qureshi AI, Toyoda K. Effect of Heart Rate Variabilities on Outcome After Acute Intracerebral Hemorrhage: A Post Hoc Analysis of ATACH-2. J Am Heart Assoc. 2021 Aug 17;10(16):e020364. doi: 10.1161/JAHA.120.020364. Epub 2021 Aug 13.
Results Reference
derived
PubMed Identifier
34292474
Citation
Shoamanesh A, Cassarly C, Morotti A, Romero JM, Oliveira-Filho J, Schlunk F, Jessel M, Butcher K, Gioia L, Ayres A, Vashkevich A, Schwab K, Afzal MR, Martin RH, Qureshi AI, Greenberg SM, Rosand J, Goldstein JN; ATACH-2 and NETT investigators. Intensive Blood Pressure Lowering and DWI Lesions in Intracerebral Hemorrhage: Exploratory Analysis of the ATACH-2 Randomized Trial. Neurocrit Care. 2022 Feb;36(1):71-81. doi: 10.1007/s12028-021-01254-9. Epub 2021 Jul 22.
Results Reference
derived
PubMed Identifier
34210824
Citation
Fukuda-Doi M, Yamamoto H, Koga M, Doi Y, Qureshi AI, Yoshimura S, Miwa K, Ishigami A, Shiozawa M, Omae K, Ihara M, Toyoda K. Impact of Renal Impairment on Intensive Blood-Pressure-Lowering Therapy and Outcomes in Intracerebral Hemorrhage: Results From ATACH-2. Neurology. 2021 Aug 31;97(9):e913-e921. doi: 10.1212/WNL.0000000000012442. Epub 2021 Jul 1.
Results Reference
derived
PubMed Identifier
34144995
Citation
Yogendrakumar V, Ramsay T, Menon BK, Qureshi AI, Saver JL, Dowlatshahi D. Hematoma Expansion Shift Analysis to Assess Acute Intracerebral Hemorrhage Treatments. Neurology. 2021 Aug 24;97(8):e755-e764. doi: 10.1212/WNL.0000000000012393. Epub 2021 Jun 18.
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derived
PubMed Identifier
33219136
Citation
Toyoda K, Palesch YY, Koga M, Foster L, Yamamoto H, Yoshimura S, Ihara M, Fukuda-Doi M, Okazaki S, Tanaka K, Miwa K, Hasegawa Y, Shiokawa Y, Iwama T, Kamiyama K, Hoshino H, Steiner T, Yoon BW, Wang Y, Hsu CY, Qureshi AI; ATACH-2 Trial Investigators. Regional Differences in the Response to Acute Blood Pressure Lowering After Cerebral Hemorrhage. Neurology. 2021 Feb 2;96(5):e740-e751. doi: 10.1212/WNL.0000000000011229. Epub 2020 Nov 20.
Results Reference
derived
PubMed Identifier
32838673
Citation
Qureshi AI, Huang W, Lobanova I, Hanley DF, Hsu CY, Malhotra K, Steiner T, Suarez JI, Toyoda K, Yamamoto H; Antihypertensive Treatment of Cerebral Hemorrhage 2 Trial Investigators. Systolic Blood Pressure Reduction and Acute Kidney Injury in Intracerebral Hemorrhage. Stroke. 2020 Oct;51(10):3030-3038. doi: 10.1161/STROKEAHA.120.030272. Epub 2020 Aug 25.
Results Reference
derived
PubMed Identifier
32623977
Citation
Fukuda-Doi M, Yamamoto H, Koga M, Palesch YY, Durkalski-Mauldin VL, Qureshi AI, Yoshimura S, Okazaki S, Miwa K, Okada Y, Ueda T, Okuda S, Nakahara J, Suzuki N, Toyoda K. Sex Differences in Blood Pressure-Lowering Therapy and Outcomes Following Intracerebral Hemorrhage: Results From ATACH-2. Stroke. 2020 Aug;51(8):2282-2286. doi: 10.1161/STROKEAHA.120.029770. Epub 2020 Jul 6.
Results Reference
derived
PubMed Identifier
32585668
Citation
Qureshi AI, Foster LD, Lobanova I, Huang W, Suarez JI. Intensive Blood Pressure Lowering in Patients with Moderate to Severe Grade Acute Cerebral Hemorrhage: Post Hoc Analysis of Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH)-2 Trial. Cerebrovasc Dis. 2020;49(3):244-252. doi: 10.1159/000506358. Epub 2020 Jun 25.
Results Reference
derived
PubMed Identifier
30421455
Citation
Toyoda K, Koga M, Yamamoto H, Foster L, Palesch YY, Wang Y, Sakai N, Hara T, Hsu CY, Itabashi R, Sato S, Fukuda-Doi M, Steiner T, Yoon BW, Hanley DF, Qureshi AI; ATACH-2 Trial Investigators. Clinical Outcomes Depending on Acute Blood Pressure After Cerebral Hemorrhage. Ann Neurol. 2019 Jan;85(1):105-113. doi: 10.1002/ana.25379. Epub 2019 Jan 7.
Results Reference
derived
PubMed Identifier
30418098
Citation
Moullaali TJ, Wang X, Martin RH, Shipes VB, Qureshi AI, Anderson CS, Palesch YY. Statistical analysis plan for pooled individual patient data from two landmark randomized trials (INTERACT2 and ATACH-II) of intensive blood pressure lowering treatment in acute intracerebral hemorrhage. Int J Stroke. 2019 Apr;14(3):321-328. doi: 10.1177/1747493018813695. Epub 2018 Nov 12.
Results Reference
derived
PubMed Identifier
29789395
Citation
Qureshi AI, Palesch YY, Foster LD, Barsan WG, Goldstein JN, Hanley DF, Hsu CY, Moy CS, Qureshi MH, Silbergleit R, Suarez JI, Toyoda K, Yamamoto H; ATACH 2 Trial Investigators. Blood Pressure-Attained Analysis of ATACH 2 Trial. Stroke. 2018 Jun;49(6):1412-1418. doi: 10.1161/STROKEAHA.117.019845. Epub 2018 May 22.
Results Reference
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PubMed Identifier
29710119
Citation
Shoamanesh A, Morotti A, Romero JM, Oliveira-Filho J, Schlunk F, Jessel MJ, Ayres AM, Vashkevich A, Schwab K, Afzal MR, Cassarly C, Martin RH, Qureshi AI, Greenberg SM, Rosand J, Goldstein JN; Antihypertensive Treatment of Acute Cerebral Hemorrhage 2 (ATACH-2) and the Neurological Emergencies Treatment Trials (NETT) Network Investigators. Cerebral Microbleeds and the Effect of Intensive Blood Pressure Reduction on Hematoma Expansion and Functional Outcomes: A Secondary Analysis of the ATACH-2 Randomized Clinical Trial. JAMA Neurol. 2018 Jul 1;75(7):850-859. doi: 10.1001/jamaneurol.2018.0454.
Results Reference
derived
PubMed Identifier
28701501
Citation
Morotti A, Boulouis G, Romero JM, Brouwers HB, Jessel MJ, Vashkevich A, Schwab K, Afzal MR, Cassarly C, Greenberg SM, Martin RH, Qureshi AI, Rosand J, Goldstein JN; ATACH-II and NETT investigators. Blood pressure reduction and noncontrast CT markers of intracerebral hemorrhage expansion. Neurology. 2017 Aug 8;89(6):548-554. doi: 10.1212/WNL.0000000000004210. Epub 2017 Jul 12.
Results Reference
derived
PubMed Identifier
28628707
Citation
Morotti A, Brouwers HB, Romero JM, Jessel MJ, Vashkevich A, Schwab K, Afzal MR, Cassarly C, Greenberg SM, Martin RH, Qureshi AI, Rosand J, Goldstein JN; Antihypertensive Treatment of Acute Cerebral Hemorrhage II and Neurological Emergencies Treatment Trials Investigators. Intensive Blood Pressure Reduction and Spot Sign in Intracerebral Hemorrhage: A Secondary Analysis of a Randomized Clinical Trial. JAMA Neurol. 2017 Aug 1;74(8):950-960. doi: 10.1001/jamaneurol.2017.1014.
Results Reference
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PubMed Identifier
23647568
Citation
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Results Reference
derived
PubMed Identifier
23230457
Citation
Toyoda K, Sato S, Koga M, Yamamoto H, Nakagawara J, Furui E, Shiokawa Y, Hasegawa Y, Okuda S, Sakai N, Kimura K, Okada Y, Yoshimura S, Hoshino H, Uesaka Y, Nakashima T, Itoh Y, Ueda T, Nishi T, Gotoh J, Nagatsuka K, Arihiro S, Yamaguchi T, Minematsu K. Run-up to participation in ATACH II in Japan. J Vasc Interv Neurol. 2012 Aug;5(supp):1-5.
Results Reference
derived
PubMed Identifier
22989898
Citation
Sato S, Yamamoto H, Qureshi AI, Palesch YY, Toyoda K; ATACH-II study group. [Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH)-II at Japan site: study design and advance construction of domestic research network]. Rinsho Shinkeigaku. 2012;52(9):642-50. doi: 10.5692/clinicalneurol.52.642. Japanese.
Results Reference
derived
Links:
URL
https://drive.google.com/file/d/0B4XP2p9l3yybYk1sX2pBYm1LSFh1cEZndHoySkVQZUxJN2Jz/view?usp=sharing
Description
Study protocol
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://drive.google.com/file/d/0B4XP2p9l3yybYk1sX2pBYm1LSFh1cEZndHoySkVQZUxJN2Jz/view?usp=sharing
Available IPD/Information Identifier
Protocol

Learn more about this trial

Antihypertensive Treatment of Acute Cerebral Hemorrhage-II

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