China Antihypertensive Trial in Acute Ischemic Stroke

Not Applicable

Completed

Conditions: Ischemic Stroke

Interventions: Other: Active antihypertensive treatment

Registration Number: NCT01840072

Lead Sponsor: Tulane University

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

Detailed 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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 4071

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active antihypertensive treatment	Active antihypertensive treatment	Active antihypertensive treatment

Primary Outcome Measures

Name	Time	Method
A Combination of Death Within 14 Days After Randomization and Major Disability at 14 Days or at Hospital Discharge if Earlier Than 14 Days.	2 weeks	Major disability was defined as a score of 3 to 5 on the modified Rankin Scale at 14 days after randomization. Scores on the modified Rankin Scale range from 0 to 6, with a score of 0 indicating no symptoms; a score of 5 indicating severe disability (ie, bedridden, incontinent, or requiring constant nursing care and attention); and a score of 6 indicating death.

Secondary Outcome Measures

Name	Time	Method
Cognitive Function (the Mini-Mental State Examination)	Three months	Cognitive function was measured by the Mini-Mental State Examination at 3 months after randomization. The MMSE contains 20 items that test cognitive performance in domains including orientation, registration, attention and calculation, recall, language, and visual construction. MMSE scores were divided into three ordinal categories: 24-30 (no cognitive impairment), 19-23 (mild cognitive impairment), and 0-17 (severe cognitive impairment).
Quality of Life	3 months	Due to limited funding, quality of life data were not collected.
Long-term Neurological and Functional Status	Three months	Those patients who were still alive at hospital discharge were contacted by telephone to set up a follow-up clinical visit. Neurological function was assessed by the modified Rankin scale at the 3-month post-treatment follow-up visit. Scores on the modified Rankin Scale range from 0 to 6, with a score of 0 indicating no symptoms; a score of 5 indicating severe disability (ie, bedridden, incontinent, or requiring constant nursing care and attention); and a score of 6 indicating death. Major disability was defined as a score of 3 to 5 on the modified Rankin Scale.
Other Vascular Events	3 months	Those patients who are still alive at hospital discharge will be contacted by telephone to set up a follow-up clinical visit. Information of vascular events, such as myocardial infarction, will be collected.
A Combination of All-cause Mortality and Major Disability at the 3-month Post-treatment Follow-up.	3 months	Major disability was defined as a score of 3 to 5 on the modified Rankin Scale at 3 months after randomization. Scores on the modified Rankin Scale range from 0 to 6, with a score of 0 indicating no symptoms; a score of 5 indicating severe disability (ie, bedridden, incontinent, or requiring constant nursing care and attention); and a score of 6 indicating death
Mortality	3 months	Those patients who are still alive at hospital discharge will be contacted by telephone to set up a follow-up clinical visit. Information on clinical deaths will be obtained.
Recurrent Stroke	3 months	Those patients who are still alive at hospital discharge will be contacted by telephone to set up a follow-up clinical visit. Information of recurrent stroke will be collected.
Cognitive Function (Montreal Cognitive Assessment)	Three months	Cognitive function was measured by Montreal Cognitive Assessment at 3 months after randomization. The MoCA is a 30-item test that evaluates the following seven cognitive domains: visuospatial/executive functions, naming, memory, attention, language, abstraction, and orientation. One point is added for participants with education \<12 years. Scores on the MoCA range from 0 to 30 and cognitive impairment was defined as a score of \<26.