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.
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.
Patients with Transient Ischemic attack or brain infarction of unknown cause (no ipsilateral internal carotid artery origin stenosis greater than 70%, no ipsilateral severe intracranial stenosis of an artery supplying the infarcted area, no definite cardiac source of embolism) in the preceding 6 months and atherosclerotic plaques.
≥ 4 mm in the aortic arch, or patients with a peripheral event (e.g. renal infarct) in the preceding 6 months and plaque ≥ 4 mm in the thoracic aorta above the origin of the embolized artery.
- Aspirin (stroke prevention) Drug
Intervention Desc: Antiplatelet agent; inhibits thromboxane A2
- Clopidogrel (Plavix®)Drug
Other Names: Plavix Intervention Desc: Antiplatelet agent
- Warfarin (Coumadin®)Drug
Other Names: Coumadin; Acenocoumarol Intervention Desc: Warfarin ARM 1: Kind: Experimental Label: Warfarin Description: Warfarin
- Clopidogrel-aspirin Drug
Other Names: Clopidogrel-aspirin Intervention Desc: Clopidogrel-aspirin ARM 1: Kind: Experimental Label: Clopidogrel-aspirin Description: Clopidogrel-aspirin
- Allocation: Randomized
- Masking: Open Label
- Purpose: Prevention
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
Patients will be randomized to receive either warfarin titrated to yield an international normalized ratio (INR) of 2.0-3.0 or 75-325 mg of aspirin plus 75 mg clopidogrel per day. Patients will be followed by 4 monthly reviews from randomization to the end of the study.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Recurrent stroke, acute myocardial infarction, peripheral embolism, vascular death.|
|Primary||New vascular events assessed every 4 months including stroke, myocardial infarction (MI), peripheral events, and vascular death||every 4 months||Yes|
|Secondary||Recurrent brain infarction||during the trial||Yes|
|Secondary||brain infarction and transient ischemic attack (TIA)||during the studing||Yes|
|Secondary||new vascular events and revascularization procedure||during the trial||Yes|
|Secondary||vascular death||during the trial||No|
|Secondary||death from all causes||during the trial||No|
|Secondary||combination of primary end-point and TIA||during the trial||Yes|
|Secondary||revascularization procedures||during the trial||Yes|
|Secondary||urgent rehospitalization for ischemic||during the trial||Yes|