At a glance
ClinicalIndex Comparison Record- ✓Age ≥55 years at enrollment
- ✓Ages 50-54 or 90-120 days post-stroke if patient has ≥2 additional risk factors (diabetes, hypertension, smoking, obesity, prior vascular disease, end-organ damage, or hyperlipidemia)
- ✓Ischemic stroke confirmed by imaging, occurring within past 90 days (or 90-120 days with risk factors)
- ✕Hemorrhagic stroke (must be ruled out by imaging)
- ✕Brain tumor, severe renal or hepatic insufficiency
- ✕Active peptic ulcer disease or severe coronary artery disease including unstable angina or MI within 3 months
- ✕History of hemostatic disorder or systemic bleeding
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes: A Double-blind, Active and Placebo Controlled Study of Aggrenox vs. Clopidogrel, With and Without Micardis
In Brief
A Phase 4 clinical trial evaluating Aggrenox, Clopidogrel placebo, and 4 other interventions for Stroke. Completed, enrolled 20,332 participants across 667 sites in 36 countries.
Detailed Summary
The purpose of the trial is to determine if extended-release dipyridamole + aspirin \[Aggrenox, Asasa ntin\] is superior to clopidogrel \[Plavix\], and if telmisartan \[Micardis, Gliosartan, Kinzal, Kinzalm ono, Predxal, Pritor, Samertan, Telmisartan\] is superior to placebo, in the presence of background antihypertensive therapy, in prevention of a second stroke in patients who have recently suffered a stroke and therefore are at high risk of suffering another one.
Study Details
Timeline
Interventions
25mg aspirin, 200 mg dipyridamole
25mg aspirin, 200 mg dipyridamole
placebo
placebo
80 mg micardis
80 mg micardis
placebo
placebo
75 mg clopidogrel
75 mg clopidogrel
placebo
placebo