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Evidence-Based Medicine 2009;14:47; doi:10.1136/ebm.14.2.47
Copyright © 2009 by the BMJ Publishing Group Ltd.

THERAPEUTICS

Telmisartan did not prevent recurrent stroke or major cardiovascular events

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

S Yusuf

Dr S Yusuf, McMaster University, Hamilton, Ontario, Canada; yusufs@mcmaster.ca


STUDY DESIGN

Design:

randomised placebo-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:

telmisartan, 80 mg/d (n = 10 146), or placebo (n = 10 186). Patients were also randomised to 1 of 2 antiplatelet regimens (see Sacco abstract).

Outcomes:

recurrent stroke of any type, a composite end point of major cardiovascular events (stroke, myocardial infarction, worsening or new heart failure, or death from cardiovascular causes), and new-onset diabetes. The trial had 91% power to detect a relative risk reduction of 15% in . . . [Full text of this article]


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