Overview

This trial is active, not recruiting.

Condition ischemic stroke
Treatment active antihypertensive treatment
Sponsor Tulane University Health Sciences Center
Collaborator Soochow University
Start date August 2009
End date May 2013
Trial size 4071 participants
Trial identifier NCT01840072, 140815

Summary

We designed a randomized controlled clinical trial to test:

- The effectiveness of blood pressure reduction among patients with acute ischemic stroke (within 48 hours of onset) on the primary outcome, a combination of death within 14 days after randomization and dependency (modified Rankin scale ≥3) at 14 day or at the time of discharge, if that occurred before 14 days.

- The effectiveness of blood pressure reduction among patients with acute ischemic stroke (within 48-hours of onset) on secondary outcomes:

- Combination of all-cause mortality and dependency over 3, 12, and 24 months of follow-up

- Combined vascular disease events over 3, 12, and 24 months of follow-up (vascular deaths, non-fatal stroke, non-fatal myocardial infarction, coronary revascularization, hospitalized or treated angina, hospitalized or treated congestive heart failure, and hospitalized or treated peripheral arterial disease)

- Recurrent fatal and non-fatal stroke over 3, 12, and 24 months of follow-up

- Neurological functional status measured by NIH Stroke Score and modified Rankin scale at 14 day or discharge after randomization, and over 3, 12, and 24 months of follow-up

- All-cause mortality over 3, 12, and 24 months of follow-up

- Duration of initial hospitalization

- Changes in systolic and diastolic blood pressure within 24 hours and over 7 days, and 14 days

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Active antihypertensive treatment
active antihypertensive treatment
Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization.
(No Intervention)
Discontinue all home BP medications.

Primary Outcomes

Measure
A combination of death within 14 days after randomization and dependency (modified Rankin scale ≥3) at 14 day or at the time of discharge, if that occurred before 14 days.
time frame: 2 weeks
Neurological dysfunction (NIH Stroke Scale, NIHSS)
time frame: 2 weeks

Secondary Outcomes

Measure
Mortality
time frame: 3, 12, and 24 months
Recurrent stroke
time frame: 3, 12 and 24 months
Other vascular events
time frame: 3, 12 and 24 months
Long-term neurological and functional status
time frame: 3, 12 and 24 months
Cognitive function
time frame: 3, 12 and 24 months
Quality of life
time frame: 3, 12 and 24 months

Eligibility Criteria

Male or female participants at least 22 years old.

Inclusion Criteria: - Age ≥22 years - Ischemic stroke onset within 48 hours confirmed by imaging (CT scan or MRI) study - Systolic BP≥140 and <220 mm Hg and diastolic BP≥80 mm Hg - No contraindications to antihypertensive treatment - Able and willing to sign informed consent by patients or their direct family members Exclusion Criteria: - Individuals with hemorrhagic stroke - Individuals with severe heart failure (NY Heart Association class III and IV), myocardial infarction, unstable angina, aortic dissection and cerebrovascular stenosis - Individuals in a deep coma - Individuals with resistant hypertension [systolic BP ≥170 mm Hg despite use of 4 or more antihypertensive medications for half a year or longer] - Intravenous thrombolytic therapy (such as intravenous rtPA) - Individuals who are unable to participate in follow-up examination - Current pregnant women

Additional Information

Official title Inner Mongolia Stroke Project
Principal investigator Jiang He, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by Tulane University Health Sciences Center.