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Acute Candesartan Cilexetil Evaluation in Stroke Survivors
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Status:
Trial recruitment halted 3/2001 after analysis of 342 randomised patients (339 valid for statistical evaluation). Results published July 2003.
Purpose:
To evaluate the effectiveness of an early, moderate BP reduction in patients with acute cerebral ischemia in comparison to restrictive antihypertensive therapy.
Year Started:
1998
Year Finished:
2001
Year Presented:
2001
Design:
Double-blind, randomized, multicenter trial with a planned enrollment of 500 patients. 342 patients randomized from 53 centers.
Inclusion Criteria
Initial BP >200/110, acute cerebral ischemia and motor paresis.
Exclusion Criteria
Patients with occlusion or >70% stenosis of the internal carotid artery, malignant hypertension, cardiac failure, high-grade aortic stenosis or mitral stenosis, unstable angina pectoris.
Patient Involvement:
Patients randomized to receive AT1 receptor antagonist candesartan cilexitil or placebo for 7 days. The placebo group is treated with candesartan if they are hypertensive after 7 days. Normotensive patients are followed up but not treated. The treatment group is also continued on candesartan. If hypertension remains, a combination therapy with other substance classes is possible. Follow-up period of 12 months.
Primary Outcome:
Patient morbidity (functional status as measured with Rankin Scale and Barthel Index, degree of motor deficit by NIH scale) and mortaility rates after 3 months.
Results:
Combined endpoint of total mortality, cerebral complications and cardiovascular complications, was reduced by 47.5 percent for patients treated with Atacand (4-16 mg) initiated within 72 hrs post stroke.
Source of Information:
Abstracts of major ongoing stroke trials. Stroke 29: 2225, 1998. Stroke. 2000;31:2536. Astra Zeneca press release 12/2001 reported on Doctors Guide web site (www.docguide.com). Stroke. 2003;34:1699-1703.
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This information last updated on: 7/18/2002
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