Aortic Arch Related Cerebral Hazard Trial (ARCH)

Phase 3 Completed 350 enrolled Assistance Publique - Hôpitaux de Paris Bristol-Myers Squibb · collab National Health and Medical Research Council, Australia · collab Sanofi · collab

RandomizedParallel-groupOpen-labelPrevention

Summary

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.

Timeline

Start: 2002-02
Primary completion: 2010-12
Completion: 2012-07

Outcome

Missed primary endpoint

paper The primary end point occurred in 7.6% (13/172) and 11.3% (20/177) of patients on A+C and on warfarin, respectively (log-rank, P=0.2). PMID 24699050 ↗

Publications

Amarenco P, Davis S, Jones EF, Cohen AA, Heiss WD, Kaste M, Laouenan C, Young D, Macleod M, Donnan GA; Aortic Arch Related Cerebral Hazard Trial Investigators. Clopidogrel plus aspirin versus warfarin in patients with stroke and aortic arch plaques. Stroke. 2014 May;45(5):1248-57. doi: 10.1161/STROKEAHA.113.004251. Epub 2014 Apr 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aspirin	Small molecule	75 mg	—
Subject	Aspirin	Small molecule	150 mg	—
Subject	Clopidogrel	Small molecule	75 mg	—
Comparator	Warfarin	Small molecule	—	Oral