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Evidence-Based Medicine 2009;14:46-47; doi:10.1136/ebm.14.2.46
Copyright © 2009 by the BMJ Publishing Group Ltd.

THERAPEUTICS

Aspirin plus extended-release dipyridamole and clopidogrel were similarly effective for preventing recurrent stroke

The first 150 words of the full text of this article appear below.

R L Sacco

Dr R L Sacco, University of Miami, Miami, FL, USA; rsacco@med.miami.edu


STUDY DESIGN

Design:

randomised controlled trial with 2 x 2 factorial design (Prevention Regimen for Effectively Avoiding Second Strokes [PRoFESS]). ClinicalTrials.gov NCT00153062 [ClinicalTrials.gov] .

Allocation concealment:

concealed.*

Blinding:

{blinded (patients, clinicians, data collectors, outcome assessors, safety committee, and data analysts)}{dagger}.*


STUDY QUESTION

Setting:

695 centres in 35 countries worldwide.

Patients:

20 332 patients >=50 years of age (mean age 66 y, 64% men) who had had an ischaemic stroke in the previous 120 days and were clinically and neurologically stable.

Intervention:

aspirin, 25 mg, plus extended-release dipyridamole (ERDP), 200 mg, twice daily (n = 10 181) or clopidogrel, 75 mg, once daily (n = 10 151). Patients were also randomised to telmisartan or placebo (see Yusuf abstract).

Outcomes:

recurrent stroke of any type, a composite end point (stroke, myocardial infarction, or death from vascular causes), and major bleeding. The trial had >82% power to reject the inferiority null . . . [Full text of this article]

Michael A Sloan

University of South Florida, Tampa, Florida, USA


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