Safety and Efficacy of Therapeutic INduced HYPERTENSION in Acute Non-cardioembolic Ischemic Stroke (SETIN-HYPERTENSION)
- Registration Number
- NCT01600235
- Lead Sponsor
- Samsung Medical Center
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 170
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Phenylephrine Phenylephrine Phenylephrine induced-hypertension arm
- Primary Outcome Measures
Name Time Method Primary outcome Day 0 and Day 7 2 points improvement in NIH stroke scale (NIHSS) between days 0 and 7
- Secondary Outcome Measures
Name Time Method Minor safety outcome 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 1. Intracranial hemorrhage on follow-up MRI
2. Side effects including headache, arrhythmia, chest pain, dysuria, or gastrointestinal hemorrhageSecondary efficacy outcome Day 90 for 1, 2 and Day 7 for 3 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 MRIMajor safety outcome 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 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
Trial Locations
- Locations (1)
Samsung Medical Center, Sungkyunkwan University School of Medicine
🇰🇷Seoul, Korea, Republic of