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Controlling Hypertension After Severe Cerebrovascular Event (CHASE)

Primary Purpose

Severe Stroke, Acute Stroke, Hypertension

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Individualized BP lowering
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Stroke focused on measuring Severe Stroke, Acute Stroke, Antihypertension, mortality, disability, clinical trial

Eligibility Criteria

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

Inclusion Criteria:

  1. age ≥ 18 years;
  2. the randomly assigned BP-lowering regimen is able to be commenced within 72 h after the onset of stroke (ischemic or hemorrhagic), confirmed by a computed tomography (CT) or magnetic resonance imaging (MRI) scan of the brain (if the precise timing of the onset of symptoms or signs of the qualifying event is unknown, then the time of onset will be taken as the last time the patient was known to be well);
  3. GCS on admission ≤ 12 or NIHSS on admission ≥ 11;
  4. there are at least two SBP measurements of ≥ 150 and ≤ 210 mmHg, recorded ≥5 min apart (patients with an initial SBP < 150 mmHg may be randomized when the SBP fulfils entry criteria on rechecking up to 72 h after the onset of stroke);
  5. written informed consent is able to be obtained directly from the patient or an appropriate surrogate, based on local ethics committee recommendations.

Exclusion Criteria:

  1. patients who have received thrombolytic therapy, embolectomy, or decompressive craniectomy for the current stroke;
  2. patients with subarachnoid hemorrhage;
  3. known definite contraindication to acute BP lowering (e.g. known severe carotid, vertebral, or cerebral arterial stenosis, Moyamoya disease or Takayasu's arteritis, high grade stenotic valvular heart disease);
  4. secondary to a structural abnormality in the brain (e.g. an arteriovenous malformation, intracranial aneurysm, tumor, or trauma);
  5. unstable vital signs and requiring the use of vasoactive agents;
  6. known existing dementia or prestroke disability (e.g. score 3-5 on the modified Rankin scale);
  7. concomitant medical illness that would interfere with the outcome assessments and/or follow-up (advanced cancer; severe pulmonary dysfunction [forced expiratory volume in 1 s < 50%]; severe cardiac dysfunction [ejection fraction ≤ 50%]; severe hepatic failure [Child-Pugh score ≥ 7]; severe renal failure [glomerular filtration rate ≤ 30 mL/min or serum creatinine ≥ 4 mg/dL]);
  8. patients who are currently participating in other investigational trials;
  9. patients who are considered to have a high likelihood of not adhering to the study treatment or the follow-up regimen.

Sites / Locations

  • Ankang Central Hospital
  • Baoji Central Hospital
  • Hanzhong Central Hospital
  • Shangluo Central Hospital
  • Tongchuan Mining Hospital
  • Tongchuan People's Hospital
  • Weinan Central Hospital
  • Xi'an 141 Hospital
  • Department of Neurology, Xijing Hospital, Fourth Military Medical University
  • Tangdu Hospital
  • The First Affiliated Hospital of Xi'an Jiaotong University
  • Shaanxi Provincial People's Hospital
  • 521 Hospital of NORINCO Group
  • The First Affiliated Hospital of Xi'an Medical University
  • Xi'an Central Hospital
  • Xi'an Gaoxin Hospital
  • Xi'an No.3 Hospital
  • Xi'an No.4 Hospital
  • Xi'an No.9 Hospital
  • Xi'an Traditional Chinese Medicine Hospital
  • Xi'an XD Group Hospital
  • Xianyang Central Hospital
  • 215 Hospital of Shaanxi NI
  • Yan'an University Affiliated Hospital
  • Yulin No.2 Hospital
  • Yulin No.1 Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Individualized BP lowering

Guideline recommended BP lowering

Arm Description

Management policy is to lower the systolic or diastolic BP by 10-15% within 2 hours of randomization and sustained for 7 days. Sites were provided with protocols for different intravenous agents and used whichever routinely available drugs were in their hospital.

Patients received management of BP based on the standard guidelines at the time, as published by the Chinese Society of Neurology (CSN) in 2014. The attending clinician may consider commencing BP treatment and sustained for 7 days if the systolic BP > 200 mmHg or diastolic BP >110 mmHg in patients with ischemic stroke, and systolic BP > 180 mmHg or diastolic BP > 110 mmHg in patients with cerebral hemorrhage.

Outcomes

Primary Outcome Measures

Death or major disability (the modified Rankin scale ≥ 3)
Components of modified Rankin Scale score:0,No symptoms;1,No significant disability despite symptoms;2,Slight disability;3,Moderate disability requiring some help, but able to walk without assistance;4,Moderate severe disability;5,Severe disability;6,Death.

Secondary Outcome Measures

Ability of activities of daily living at day 90 of enrollment (defined by Barthel Index)
Barthel Index is a 100-point scale (0-100), where higher scores indicate better ability of activities of daily living

Full Information

First Posted
November 27, 2016
Last Updated
March 30, 2019
Sponsor
Xijing Hospital
Collaborators
Tang-Du Hospital, Xi'an Central Hospital, Shaanxi Provincial People's Hospital, Hanzhong Central Hospital, Yan'an University Affiliated Hospital, Xiangyang Central Hospital, Xi'an 141 Hospital, Shangluo Central Hospital, 215 Hospital of Shaanxi NI, Yulin No.2 Hospital, Yulin No.1 Hospital, Ankang Central Hospital, First Affiliated Hospital Xi'an Jiaotong University, Xi'an Gaoxin Hospital, 521 Hospital of NORINCO Group, The First Affiliated Hospital of Xi'an Medical University, Xi'an No.3 Hospital, Xi'an No.4 Hospital, Xi'an No.9 Hospital, Xi'an XD Group Hospital, Xi'an Traditional Chinese Medicine Hospital, Baoji Central Hospital, Weinan Central Hospital, Tongchuan Mining Hospital, Tongchuan People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02982655
Brief Title
Controlling Hypertension After Severe Cerebrovascular Event
Acronym
CHASE
Official Title
A Multi-center Randomised Controlled Trial to Explore the Ideal Individualized Anti-hypertension Strategies in Patients With Severe Stroke at Acute Stage
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
January 2017 (undefined)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
November 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital
Collaborators
Tang-Du Hospital, Xi'an Central Hospital, Shaanxi Provincial People's Hospital, Hanzhong Central Hospital, Yan'an University Affiliated Hospital, Xiangyang Central Hospital, Xi'an 141 Hospital, Shangluo Central Hospital, 215 Hospital of Shaanxi NI, Yulin No.2 Hospital, Yulin No.1 Hospital, Ankang Central Hospital, First Affiliated Hospital Xi'an Jiaotong University, Xi'an Gaoxin Hospital, 521 Hospital of NORINCO Group, The First Affiliated Hospital of Xi'an Medical University, Xi'an No.3 Hospital, Xi'an No.4 Hospital, Xi'an No.9 Hospital, Xi'an XD Group Hospital, Xi'an Traditional Chinese Medicine Hospital, Baoji Central Hospital, Weinan Central Hospital, Tongchuan Mining Hospital, Tongchuan People's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this academic lead study is to explore ideal blood pressure targets and optimum individualized anti-hypertension strategies in acute severe stroke.
Detailed Description
Of high mortality and morbidity, severe stroke is associated with devastating damages in neurologic, respiratory, circulatory and many other systems. The outcomes of patients with severe stroke depend largely on medical strategies on acute stage, especially on blood pressure (BP) management. Unfortunately, so far no ideal BP range has been scientifically determined for patients with acute severe stroke. The CHASE study aims to provide reliable data on the effects of individualized anti-hypertension strategy in patients with acute severe stroke (target recruitment 250) compared to standard guideline-based management of BP (target recruitment 250). Patients presenting with acute (<72h) severe stroke (GCS ≦ 12 or NIHSS ≧ 11) and elevated BP (systolic blood pressure ≧150 mmHg or diastolic blood pressure ≧ 100 mmHg) will be randomly assigned to individualized anti-hypertension treatment or guideline-based treatment for 7 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Stroke, Acute Stroke, Hypertension
Keywords
Severe Stroke, Acute Stroke, Antihypertension, mortality, disability, clinical trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Individualized BP lowering
Arm Type
Experimental
Arm Description
Management policy is to lower the systolic or diastolic BP by 10-15% within 2 hours of randomization and sustained for 7 days. Sites were provided with protocols for different intravenous agents and used whichever routinely available drugs were in their hospital.
Arm Title
Guideline recommended BP lowering
Arm Type
Active Comparator
Arm Description
Patients received management of BP based on the standard guidelines at the time, as published by the Chinese Society of Neurology (CSN) in 2014. The attending clinician may consider commencing BP treatment and sustained for 7 days if the systolic BP > 200 mmHg or diastolic BP >110 mmHg in patients with ischemic stroke, and systolic BP > 180 mmHg or diastolic BP > 110 mmHg in patients with cerebral hemorrhage.
Intervention Type
Procedure
Intervention Name(s)
Individualized BP lowering
Primary Outcome Measure Information:
Title
Death or major disability (the modified Rankin scale ≥ 3)
Description
Components of modified Rankin Scale score:0,No symptoms;1,No significant disability despite symptoms;2,Slight disability;3,Moderate disability requiring some help, but able to walk without assistance;4,Moderate severe disability;5,Severe disability;6,Death.
Time Frame
3 months after onset
Secondary Outcome Measure Information:
Title
Ability of activities of daily living at day 90 of enrollment (defined by Barthel Index)
Description
Barthel Index is a 100-point scale (0-100), where higher scores indicate better ability of activities of daily living
Time Frame
3 months after onset

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age ≥ 18 years; the randomly assigned BP-lowering regimen is able to be commenced within 72 h after the onset of stroke (ischemic or hemorrhagic), confirmed by a computed tomography (CT) or magnetic resonance imaging (MRI) scan of the brain (if the precise timing of the onset of symptoms or signs of the qualifying event is unknown, then the time of onset will be taken as the last time the patient was known to be well); GCS on admission ≤ 12 or NIHSS on admission ≥ 11; there are at least two SBP measurements of ≥ 150 and ≤ 210 mmHg, recorded ≥5 min apart (patients with an initial SBP < 150 mmHg may be randomized when the SBP fulfils entry criteria on rechecking up to 72 h after the onset of stroke); written informed consent is able to be obtained directly from the patient or an appropriate surrogate, based on local ethics committee recommendations. Exclusion Criteria: patients who have received thrombolytic therapy, embolectomy, or decompressive craniectomy for the current stroke; patients with subarachnoid hemorrhage; known definite contraindication to acute BP lowering (e.g. known severe carotid, vertebral, or cerebral arterial stenosis, Moyamoya disease or Takayasu's arteritis, high grade stenotic valvular heart disease); secondary to a structural abnormality in the brain (e.g. an arteriovenous malformation, intracranial aneurysm, tumor, or trauma); unstable vital signs and requiring the use of vasoactive agents; known existing dementia or prestroke disability (e.g. score 3-5 on the modified Rankin scale); concomitant medical illness that would interfere with the outcome assessments and/or follow-up (advanced cancer; severe pulmonary dysfunction [forced expiratory volume in 1 s < 50%]; severe cardiac dysfunction [ejection fraction ≤ 50%]; severe hepatic failure [Child-Pugh score ≥ 7]; severe renal failure [glomerular filtration rate ≤ 30 mL/min or serum creatinine ≥ 4 mg/dL]); patients who are currently participating in other investigational trials; patients who are considered to have a high likelihood of not adhering to the study treatment or the follow-up regimen.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen Jiang, PhD
Organizational Affiliation
Department of Neurology, Xijing Hospital, Fourth Military Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Ankang Central Hospital
City
Ankang
State/Province
Shaanxi
ZIP/Postal Code
725000
Country
China
Facility Name
Baoji Central Hospital
City
Baoji
State/Province
Shaanxi
Country
China
Facility Name
Hanzhong Central Hospital
City
Hanzhong
State/Province
Shaanxi
ZIP/Postal Code
710000
Country
China
Facility Name
Shangluo Central Hospital
City
Shangluo
State/Province
Shaanxi
ZIP/Postal Code
726000
Country
China
Facility Name
Tongchuan Mining Hospital
City
Tongchuan
State/Province
Shaanxi
Country
China
Facility Name
Tongchuan People's Hospital
City
Tongchuan
State/Province
Shaanxi
Country
China
Facility Name
Weinan Central Hospital
City
Weinan
State/Province
Shaanxi
Country
China
Facility Name
Xi'an 141 Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710000
Country
China
Facility Name
Department of Neurology, Xijing Hospital, Fourth Military Medical University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Facility Name
Tangdu Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710038
Country
China
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Facility Name
Shaanxi Provincial People's Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710068
Country
China
Facility Name
521 Hospital of NORINCO Group
City
Xi'an
State/Province
Shaanxi
Country
China
Facility Name
The First Affiliated Hospital of Xi'an Medical University
City
Xi'an
State/Province
Shaanxi
Country
China
Facility Name
Xi'an Central Hospital
City
Xi'an
State/Province
Shaanxi
Country
China
Facility Name
Xi'an Gaoxin Hospital
City
Xi'an
State/Province
Shaanxi
Country
China
Facility Name
Xi'an No.3 Hospital
City
Xi'an
State/Province
Shaanxi
Country
China
Facility Name
Xi'an No.4 Hospital
City
Xi'an
State/Province
Shaanxi
Country
China
Facility Name
Xi'an No.9 Hospital
City
Xi'an
State/Province
Shaanxi
Country
China
Facility Name
Xi'an Traditional Chinese Medicine Hospital
City
Xi'an
State/Province
Shaanxi
Country
China
Facility Name
Xi'an XD Group Hospital
City
Xi'an
State/Province
Shaanxi
Country
China
Facility Name
Xianyang Central Hospital
City
Xianyang
State/Province
Shaanxi
ZIP/Postal Code
712000
Country
China
Facility Name
215 Hospital of Shaanxi NI
City
Xianyang
State/Province
Shaanxi
ZIP/Postal Code
712021
Country
China
Facility Name
Yan'an University Affiliated Hospital
City
Ya'an
State/Province
Shaanxi
Country
China
Facility Name
Yulin No.2 Hospital
City
Yulin
State/Province
Shaanxi
ZIP/Postal Code
719000
Country
China
Facility Name
Yulin No.1 Hospital
City
Yulin
State/Province
Shaanxi
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Controlling Hypertension After Severe Cerebrovascular Event

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