Acute Candesartan Cilexetil Evaluation in Stroke Survivors "ACCESS"

Completed

Phase N/A Results

Trial Description

To evaluate the effectiveness of an early, moderate BP reduction in patients with acute cerebral ischemia in comparison to restrictive antihypertensive therapy.

Interventions

  • Candesartan cilexetil (Atacand®)Drug
    Intervention Desc: AT1 receptor antagonist (antihypertensive)
  • Antihypertensives Drug
    Intervention Desc: This category includes all BP lowering drugs in stroke prevention trials

Trial Design

Double-blind, randomized, multicenter trial with a planned enrollment of 500 patients. 342 patients randomized from 53 centers.

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.

Outcomes

Type Measure Time Frame Safety Issue
Primary 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.

Sponsors

AstraZeneca GmbH Germany