Rationale, Design and Baseline Data of a Randomized, Double-Blind, Controlled Trial Comparing Two Antithrombotic Regimens (a Fixed-Dose Combination of Extended-Release Dipyridamole plus ASA with Clopidogrel) and Telmisartan versus Placebo in Patients with Strokes: The Prevention Regimen for Effectively Avoiding Second Strokes Trial (PRoFESS)
Why the study?
Does ASA + extended-release dipyridamole (vs clopidogrel) and telmisartan (vs placebo) reduce recurrent stroke in patients with recent ischemic stroke?
Population
>20,000 patients ≥50 years presenting with a stable ischemic stroke <120 days prior, mean age 66.1, 36.0%…
Comparison
Acetylsalicylic acid + extended-release… vs Clopidogrel AND/OR matching placebo
Design
RCT, randomized, 2 x 2 factorial design, double-blind
Authors
Discussion
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Implication
Outlines largest secondary stroke prevention RCT of antiplatelet regimens and telmisartan; leaves open efficacy pending outcome data.
Key Points
- To evaluate the effectiveness of ASA plus extended-release dipyridamole versus clopidogrel, and the role of telmisartan in reducing recurrent stroke risk.
- Multicenter, randomized, double-blind trial involving over 20,000 patients across 695 sites in 35 countries.
- Participants: individuals aged 50 or older with ischemic stroke < 120 days who were stable at enrollment.
- Primary outcome: recurrent stroke assessed by time-to-event analysis.
- Mean age of participants was 66.1 years, with 36% being female.
- 28.5% of strokes were due to large-vessel disease, and 52.1% due to small-vessel disease, as per TOAST criteria.
- The trial aims to assess the noninferiority and potential superiority of ASA + dipyridamole versus clopidogrel.
Structured PICO
Does ASA + extended-release dipyridamole (vs clopidogrel) and telmisartan (vs placebo) reduce recurrent stroke in patients with recent ischemic stroke?
P
Population
>20,000 patients ≥50 years presenting with a stable ischemic stroke <120 days prior, mean age 66.1, 36.0% female, multinational (35 countries).
I
Intervention
Acetylsalicylic acid (ASA) + extended-release dipyridamole (DP) AND/OR telmisartan (2x2 factorial design)
C
Comparator
Clopidogrel (for ASA+DP comparison) AND/OR matching placebo (for telmisartan comparison)
O
Outcome
Recurrent stroke (time-to-event analysis)hard clinical
The PRoFESS trial is the largest secondary stroke prevention trial designed to evaluate the efficacy of ASA plus extended-release dipyridamole versus clopidogrel, and telmisartan versus placebo.
Cite This Study
Diener et al. (2007) studied this question.