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Safety and Efficacy of Therapeutic INduced HYPERTENSION in Acute Non-cardioembolic Ischemic Stroke (SETIN-HYPERTENSION)

Primary Purpose

Stroke, Acute, Progressing Stroke

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Phenylephrine
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Acute focused on measuring Stroke, ischemic, Progression, Induced-hypertension, Phenylephrine

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with acute ischemic stroke confirmed by diffusion-weighted imaging (DWI) performed within 24 hours of symptom onset or symptom worsening(defined by a 2-point or more increase in NIH stroke scale (NIHSS)score including one or more increase in the motor score of affected upper and lower limbs in NIHSS during hospitalization or clear history of symptom worsening judged by investigator before hospitalization) confirmed by DWI performed within 24 hours of aggravation.
  • Baseline NIHSS score 4-18 points
  • Alert mental status
  • Newly developed paresis, aphasia, or neglect

Exclusion Criteria:

  • Patients underwent recanalization therapy
  • Systolic blood pressure >170 mmHg at baseline
  • Patients with history or at risk of hemorrhagic stroke
  • History of significant arrhythmia (e.g. atrial fibrillation)
  • Unable to perform MRI scans or undergo MRI scans > 24 hours of symptom onset or progression
  • Large cortical infarction on DWI (more than 1/2 of middle cerebral artery territory)
  • 3 or more cortical microbleeds on gradient-echo MRI
  • Coronary artery disease, congestive heart failure, or hypertrophic cardiomyopathy
  • Anticoagulation therapy (phenylephrine group only)
  • Patients with high-risk cardioembolic sources
  • Cervical or cerebral artery dissection or unruptured aortic/cerebral arterial aneurysm
  • Decreased consciousness
  • Pregnant or Lactating patient
  • Seizure at stroke onset
  • Life expectancy < 6 months
  • Pre-stroke modified Rankin scale (mRS) >= 2
  • Patients without informed consent

Sites / Locations

  • Samsung Medical Center, Sungkyunkwan University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Phenylephrine

Conventional treatment

Arm Description

Phenylephrine induced-hypertension arm

Control arm

Outcomes

Primary Outcome Measures

Primary outcome
2 points improvement in NIH stroke scale (NIHSS) between days 0 and 7

Secondary Outcome Measures

Secondary efficacy outcome
modified Rankin scale (mRS)≤ 2 at day 90 modified Bathel index (mBI)≥ 90 at day 90 Infarct growth or new ischemic lesion on follow-up MRI
Major safety outcome
Symptom aggravation by intracranial hemorrhage or cerebral edema (Clinical deterioration causing an increase in the NIHSS score of more than or equal to 4 points and if the hemorrhage or edema was liley to be the cause of the clinical deterioration) Myocardial infarction death from any cause
Minor safety outcome
Intracranial hemorrhage on follow-up MRI Side effects including headache, arrhythmia, chest pain, dysuria, or gastrointestinal hemorrhage

Full Information

First Posted
May 13, 2012
Last Updated
April 24, 2017
Sponsor
Samsung Medical Center
Collaborators
Inje University, Gyeongsang National University Hospital, Seoul National University Bundang Hospital, Keimyung University Dongsan Medical Center, Yeungnam University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01600235
Brief Title
Safety and Efficacy of Therapeutic INduced HYPERTENSION in Acute Non-cardioembolic Ischemic Stroke (SETIN-HYPERTENSION)
Official Title
Safety and Efficacy of Therapeutic Induced Hypertension in Patients With Acute Non-cardioembolic Ischemic Stroke: A Multicenter, Randomized, Open Label, Prospective, Phase 3 Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
Collaborators
Inje University, Gyeongsang National University Hospital, Seoul National University Bundang Hospital, Keimyung University Dongsan Medical Center, Yeungnam University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and efficacy of the induced hypertension using phenylephrine in patients with noncardioembolic ischemic stroke. The investigators hypothesized that phenylephrine induced-hypertension can result in good clinical response without serious complications in patients with noncardioembolic ischemic stroke.
Detailed Description
See below

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute, Progressing Stroke
Keywords
Stroke, ischemic, Progression, Induced-hypertension, Phenylephrine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phenylephrine
Arm Type
Experimental
Arm Description
Phenylephrine induced-hypertension arm
Arm Title
Conventional treatment
Arm Type
No Intervention
Arm Description
Control arm
Intervention Type
Drug
Intervention Name(s)
Phenylephrine
Intervention Description
Phenylephrine (0.12mg/mL) Starting dose: 10cc/hr Titration: increase 10cc/hr every 30-60min, maximum 160cc/hr rate: increase systolic blood pressure (SBP) 10-25mmHg /hr Target: initially 20% increase of initial SBP, up to improving NIHSS score or SBP 200mmHg
Primary Outcome Measure Information:
Title
Primary outcome
Description
2 points improvement in NIH stroke scale (NIHSS) between days 0 and 7
Time Frame
Day 0 and Day 7
Secondary Outcome Measure Information:
Title
Secondary efficacy outcome
Description
modified Rankin scale (mRS)≤ 2 at day 90 modified Bathel index (mBI)≥ 90 at day 90 Infarct growth or new ischemic lesion on follow-up MRI
Time Frame
Day 90 for 1, 2 and Day 7 for 3
Title
Major safety outcome
Description
Symptom aggravation by intracranial hemorrhage or cerebral edema (Clinical deterioration causing an increase in the NIHSS score of more than or equal to 4 points and if the hemorrhage or edema was liley to be the cause of the clinical deterioration) Myocardial infarction death from any cause
Time Frame
From date of randomization until the date of first documented progression by intracranial hemorrhage or cerebral edema, date of myocardial infarction, or date of death from any cause, whichever came first, assessed up to 3 months
Title
Minor safety outcome
Description
Intracranial hemorrhage on follow-up MRI Side effects including headache, arrhythmia, chest pain, dysuria, or gastrointestinal hemorrhage
Time Frame
From date of randomization until the date of first documented intracranial hemorrhage on follow-up MRI, or date of first documented side effects, whichever came first, assessed up to 3 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with acute ischemic stroke confirmed by diffusion-weighted imaging (DWI) performed within 24 hours of symptom onset or symptom worsening(defined by a 2-point or more increase in NIH stroke scale (NIHSS)score including one or more increase in the motor score of affected upper and lower limbs in NIHSS during hospitalization or clear history of symptom worsening judged by investigator before hospitalization) confirmed by DWI performed within 24 hours of aggravation. Baseline NIHSS score 4-18 points Alert mental status Newly developed paresis, aphasia, or neglect Exclusion Criteria: Patients underwent recanalization therapy Systolic blood pressure >170 mmHg at baseline Patients with history or at risk of hemorrhagic stroke History of significant arrhythmia (e.g. atrial fibrillation) Unable to perform MRI scans or undergo MRI scans > 24 hours of symptom onset or progression Large cortical infarction on DWI (more than 1/2 of middle cerebral artery territory) 3 or more cortical microbleeds on gradient-echo MRI Coronary artery disease, congestive heart failure, or hypertrophic cardiomyopathy Anticoagulation therapy (phenylephrine group only) Patients with high-risk cardioembolic sources Cervical or cerebral artery dissection or unruptured aortic/cerebral arterial aneurysm Decreased consciousness Pregnant or Lactating patient Seizure at stroke onset Life expectancy < 6 months Pre-stroke modified Rankin scale (mRS) >= 2 Patients without informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oh Young Bang, MD
Phone
82-10-3410-3599
Email
nmboy@unitel.co.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Mi Hyun Seo, RN
Phone
82-10-3410-0934
Email
mh84.seo@samsung.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oh Young Bang, MD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center, Sungkyunkwan University School of Medicine
City
Seoul
ZIP/Postal Code
135710
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suk Jae Kim, MD
Phone
82234101895
Email
sukjae.kim@gmail.com
First Name & Middle Initial & Last Name & Degree
Oh Young Bang, MD
First Name & Middle Initial & Last Name & Degree
Kwang Ho Lee, MD
First Name & Middle Initial & Last Name & Degree
Chin-Sang Chung, MD
First Name & Middle Initial & Last Name & Degree
Gyeong-Moon Kim, MD
First Name & Middle Initial & Last Name & Degree
Sung-Ji Park, MD
First Name & Middle Initial & Last Name & Degree
Suk Jae Kim, MD
First Name & Middle Initial & Last Name & Degree
Sookyung Ryoo, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
31645472
Citation
Bang OY, Chung JW, Kim SK, Kim SJ, Lee MJ, Hwang J, Seo WK, Ha YS, Sung SM, Kim EG, Sohn SI, Han MK. Therapeutic-induced hypertension in patients with noncardioembolic acute stroke. Neurology. 2019 Nov 19;93(21):e1955-e1963. doi: 10.1212/WNL.0000000000008520. Epub 2019 Oct 23.
Results Reference
derived

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Safety and Efficacy of Therapeutic INduced HYPERTENSION in Acute Non-cardioembolic Ischemic Stroke (SETIN-HYPERTENSION)

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