The ARCH is a controlled trial with a sequential design and with a prospective, randomized,
open-label, blinded-endpoint (PROBE) methodology. The objective is to compare the efficacy
and tolerance (net benefit) of two antithrombotic strategies in patients with
atherothrombosis of the aortic arch and a recent (less than 6 months) cerebral or peripheral
embolic event.
Hypothesis:
The association of clopidogrel 75 mg/d plus aspirin 75 mg/d is 25% more effective than an
oral anticoagulant (target International Normalized Ratio [INR] 2 to 3) in preventing brain
infarction, brain hemorrhage, myocardial infarction, peripheral embolism, and vascular death.
Phase:
Phase 3
Details
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborators:
Bristol-Myers Squibb National Health and Medical Research Council, Australia Sanofi