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

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ClinicalTrials.gov Identifier: NCT01600235
Recruitment Status : Recruiting
First Posted : May 17, 2012
Last Update Posted : April 26, 2017
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Stroke, Acute Progressing Stroke Drug: Phenylephrine Phase 3

Detailed Description:
See below

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2012
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Primary outcome [ Time Frame: Day 0 and Day 7 ]
    2 points improvement in NIH stroke scale (NIHSS) between days 0 and 7

Secondary Outcome Measures :
  1. Secondary efficacy outcome [ Time Frame: 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 MRI

  2. 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 ]
    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

  3. 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 ]
    1. Intracranial hemorrhage on follow-up MRI
    2. Side effects including headache, arrhythmia, chest pain, dysuria, or gastrointestinal hemorrhage

Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01600235

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
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 Hospital
Principal Investigator: Oh Young Bang, MD Samsung Medical Center
More Information

Responsible Party: Oh Young Bang, Associate Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01600235     History of Changes
Other Study ID Numbers: 2012-01-023
First Posted: May 17, 2012    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017

Keywords provided by Oh Young Bang, Samsung Medical Center:
Stroke, ischemic

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cardiotonic Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents