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

Stroke, Acute Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01600235
• Other study ID #: 2012-01-023
• Status: Recruiting
• Phase: Phase 3
• First received: May 13, 2012
• Last updated: April 24, 2017
• Start date: June 2012
• Est. completion date: December 2017

Study information

• Verified date: April 2017
• Source: Samsung Medical Center
• Contact: Oh Young Bang, MD
• Phone: 82-10-3410-3599
• Email: nmboy[@]unitel.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

See below

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Progressing Stroke
• Stroke
• Stroke, Acute

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center, Sungkyunkwan University School of Medicine	Seoul

Sponsors (6)

Lead Sponsor	Collaborator
Samsung Medical Center	Gyeongsang National University Hospital, Inje University, Keimyung University Dongsan Medical Center, Seoul National University Bundang Hospital, Yeungnam University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome	2 points improvement in NIH stroke scale (NIHSS) between days 0 and 7	Day 0 and Day 7
Secondary	Secondary efficacy outcome	modified Rankin scale (mRS)= 2 at day 90; modified Bathel index (mBI)= 90 at day 90; Infarct growth or new ischemic lesion on follow-up MRI	Day 90 for 1, 2 and Day 7 for 3
Secondary	Major safety outcome	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); Myocardial infarction; 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
Secondary	Minor safety outcome	Intracranial hemorrhage on follow-up MRI; 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