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
  Purpose

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.


Condition Intervention Phase
Stroke, Acute
Progressing Stroke
Drug: Phenylephrine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 170
Study Start Date: June 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phenylephrine
Phenylephrine induced-hypertension arm
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
No Intervention: Conventional treatment
Control arm

Detailed Description:

See below

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01600235

Contacts
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

Locations
Korea, Republic of
Samsung Medical Center, Sungkyunkwan University School of Medicine Recruiting
Seoul, Korea, Republic of, 135710
Contact: Suk Jae Kim, MD    82234101895    sukjae.kim@gmail.com   
Principal Investigator: Oh Young Bang, MD         
Sub-Investigator: Kwang Ho Lee, MD         
Sub-Investigator: Chin-Sang Chung, MD         
Sub-Investigator: Gyeong-Moon Kim, MD         
Sub-Investigator: Sung-Ji Park, MD         
Sub-Investigator: Suk Jae Kim, MD         
Sub-Investigator: Sookyung Ryoo, MD         
Sponsors and Collaborators
Samsung Medical Center
Inje University
Gyeongsang National University Hospital
Seoul National University Bundang Hospital
Keimyung University Dongsan Medical Center
Yeungnam University
Investigators
Principal Investigator: Oh Young Bang, MD Samsung Medical Center
  More Information

No publications provided

Responsible Party: Oh Young Bang, Associate Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01600235     History of Changes
Other Study ID Numbers: 2012-01-023
Study First Received: May 13, 2012
Last Updated: May 8, 2014
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
Stroke, ischemic
Progression
Induced-hypertension
Phenylephrine

Additional relevant MeSH terms:
Hypertension
Stroke
Cerebral Infarction
Vascular Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Brain Infarction
Brain Ischemia
Phenylephrine
Oxymetazoline
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on September 30, 2014