China Antihypertensive Trial in Acute Ischemic Stroke (CATIS)

Tulane University

Status

Completed

Conditions

Ischemic Stroke

Treatments

Other: Active antihypertensive treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT01840072

140815

Details and patient eligibility

About

This randomized trial tests the effect of early blood pressure reduction on major disability and death among patients with acute ischemic stroke in china.

Full description

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

Enrollment

4,071 patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

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