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

April 24, 2017 updated by: Oh Young Bang, Samsung Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

See below

Study Type

Interventional

Enrollment (Anticipated)

170

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 135710
        • Recruiting
        • Samsung Medical Center, Sungkyunkwan University School of Medicine
        • Contact:
        • Sub-Investigator:
          • Sung-Ji Park, MD
        • Sub-Investigator:
          • Sookyung Ryoo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary outcome
Time Frame: Day 0 and Day 7
2 points improvement in NIH stroke scale (NIHSS) between days 0 and 7
Day 0 and Day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 90 for 1, 2 and Day 7 for 3
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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Collaborators

Seoul National University Bundang Hospital
Inje University
Gyeongsang National University Hospital
Yeungnam University Hospital
Keimyung University Dongsan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

May 13, 2012

First Submitted That Met QC Criteria

May 16, 2012

First Posted (ESTIMATE)

May 17, 2012

Study Record Updates

Last Update Posted (ACTUAL)

April 26, 2017

Last Update Submitted That Met QC Criteria

April 24, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-01-023

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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