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 × 2 factorial design (Prevention Regimen for Effectively Avoiding Second Strokes [PRoFESS]). ClinicalTrials.gov NCT00153062.

Allocation concealment:

concealed.*

Blinding:

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

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 hypothesis with a non-inferiority margin for the hazard ratio of 1.075.

Follow-up period:

mean 2.5 years.

Patient follow-up:

99% (intention-to-treat analysis).

MAIN RESULTS

Rates of recurrent stroke were similar in the aspirin …