N/A
N=4,071
China Antihypertensive Trial in Acute Ischemic Stroke
Ischemic Stroke
Bottom Line
View on ClinicalTrials.gov: NCT01840072 ↗Enrolled (actual)
4,071
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: Primary: A Combination of Death Within 14 Days After Randomization and Major Disability at 14 Days or at Hospital Discharge if Earlier Than 14 Days. — 681; 683 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Active antihypertensive treatment (Other)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Tulane University
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY A Combination of Death Within 14 Days After Randomization and Major Disability at 14 Days or at Hospital Discharge if Earlier Than 14 Days. |
681; 683 | — |
| SECONDARY A Combination of All-cause Mortality and Major Disability at the 3-month Post-treatment Follow-up. |
502; 500 | — |
| SECONDARY Mortality |
68; 54 | — |
| SECONDARY Recurrent Stroke |
28; 43 | — |
| SECONDARY Other Vascular Events |
59; 48 | — |
| SECONDARY Long-term Neurological and Functional Status |
1.0; 1.0 | — |
| SECONDARY Cognitive Function (the Mini-Mental State Examination) |
26; 26 | — |
| SECONDARY Cognitive Function (Montreal Cognitive Assessment) |
22; 22 | — |
| SECONDARY Quality of Life |
— | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01840072). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.