ACCOST
Acute Candesartan Cilexetil Outcomes Stroke Trial
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Status:
Trial completed enrollment in October 2006, and expect to have results available by the summer 2007. This study is ongoing, but not recruiting participants.
Purpose:
To determine the safetey and efficacy of the Angiotensin Receptor Blocker (ARB) Candesartan within the first 72 hours following acute stroke.
Year Started:
2004
Design:
Interventional, double-blind, placebo-controlled, randomized, controlled trial.
Inclusion Criteria
Patients presenting with a stroke within 72 hours with a mean blood pressure >120/70 are eligible for this trial.
Exclusion Criteria
Patients with severe disability (Rankin >2), nursing home residents, renal impairment, or a history of congestive heart failure requiring treatment with ACE-Inhibitors will be excluded from this trial.
Patient Involvement:
Phase I is a four week double-blind placebo controlled RCT of Candesartan (initial dose 4mg) versus matched placebo, with titration to 8mg after two weeks. Phase II is an open label study of Candesartan versus an ACE-Inhibitor based regime with a blood pressure target of <140/85, with or without additional agents.
Primary Outcome:
All-cause mortality; mortality due to vascular causes.
Secondary Outcome:
Neurological recovery at 3 months (NIHSS), functional recovery at 3 months (mRS, Barthel).
Source of Information:
Presented at the 14th European Stroke Conference [May 2005].
Clinicaltrials.gov
Presented at the 2006 International Stroke Conference [February 2006].
Trial coordinator [November 2006].
Presented at the 2007 International Stroke Conference [February 2007].
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Web Links and Publications:
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This information last updated on: 12/30/2008
Reviewed on: 06/19/2009.
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