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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Samsung Medical Center
Sponsor:
Collaborators:
Inje University
Gyeongsang National University Hospital
Seoul National University Bundang Hospital
Keimyung University Dongsan Medical Center
Yeungnam University
Information provided by (Responsible Party):
Oh Young Bang, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01600235
First received: May 13, 2012
Last updated: May 8, 2014
Last verified: May 2014

May 13, 2012
May 8, 2014
June 2012
June 2016   (final data collection date for primary outcome measure)
Primary outcome [ Time Frame: Day 0 and Day 7 ] [ Designated as safety issue: No ]
2 points improvement in NIH stroke scale (NIHSS) between days 0 and 7
Same as current
Complete list of historical versions of study NCT01600235 on ClinicalTrials.gov Archive Site
  • Secondary efficacy outcome [ Time Frame: Day 90 for 1, 2 and Day 7 for 3 ] [ Designated as safety issue: No ]
    1. modified Rankin scale (mRS)≤ 2 at day 90
    2. modified Bathel index (mBI)≥ 90 at day 90
    3. Infarct growth or new ischemic lesion on follow-up MRI
  • Major safety outcome [ 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 ] [ Designated as safety issue: Yes ]
    1. 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)
    2. Myocardial infarction
    3. death from any cause
  • Minor safety outcome [ 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 ] [ Designated as safety issue: Yes ]
    1. Intracranial hemorrhage on follow-up MRI
    2. Side effects including headache, arrhythmia, chest pain, dysuria, or gastrointestinal hemorrhage
  • Secondary efficacy outcome [ Time Frame: Day 90 for 1, 2 and Day 7 for 3 ] [ Designated as safety issue: No ]
    1. modified Rankin scale (mRS)≤ 2 at day 90
    2. modified Bathel index (mBI)≥ 90 at day 90
    3. Infarct growth or new ischemic lesion on follow-up MRI
  • Major safety outcome [ 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 ] [ Designated as safety issue: Yes ]
    1. Symptom aggravation by intracranial hemorrhage or cerebral edema
    2. Myocardial infarction
    3. death from any cause
  • Minor safety outcome [ 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 ] [ Designated as safety issue: Yes ]
    1. Intracranial hemorrhage on follow-up MRI
    2. Side effects including headache, arrhythmia, chest pain, dysuria, or gastrointestinal hemorrhage
Not Provided
Not Provided
 
Safety and Efficacy of Therapeutic INduced HYPERTENSION in Acute Non-cardioembolic Ischemic Stroke (SETIN-HYPERTENSION)
Safety and Efficacy of Therapeutic Induced Hypertension in Patients With Acute Non-cardioembolic Ischemic Stroke: A Multicenter, Randomized, Open Label, Prospective, Phase 3 Study

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.

See below

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Stroke, Acute
  • Progressing Stroke
Drug: Phenylephrine
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
  • Experimental: Phenylephrine
    Phenylephrine induced-hypertension arm
    Intervention: Drug: Phenylephrine
  • No Intervention: Conventional treatment
    Control arm
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
170
September 2016
June 2016   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact: Oh Young Bang, MD 82-10-3410-3599 nmboy@unitel.co.kr
Contact: Mi Hyun Seo, RN 82-10-3410-0934 mh84.seo@samsung.com
Korea, Republic of
 
NCT01600235
2012-01-023
Yes
Oh Young Bang, Samsung Medical Center
Samsung Medical Center
  • Inje University
  • Gyeongsang National University Hospital
  • Seoul National University Bundang Hospital
  • Keimyung University Dongsan Medical Center
  • Yeungnam University
Principal Investigator: Oh Young Bang, MD Samsung Medical Center
Samsung Medical Center
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP