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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
350
Warfarin
Clopidogrel-aspirin
National Stroke Research Institute-Austin Health
Heidelberg Heights, Australia
Bichat Hospital Head of Neurology Department
Paris, France
New vascular events assessed every 4 months including stroke, myocardial infarction (MI), peripheral events, and vascular death
New vascular events assessed every 4 months including stroke, myocardial infarction (MI), peripheral events, and vascular death
Time frame: every 4 months
Recurrent brain infarction
Recurrent brain infarction
Time frame: during the trial
brain infarction and transient ischemic attack (TIA)
brain infarction and transient ischemic attack (TIA)
Time frame: during the studing
new vascular events and revascularization procedure
new vascular events and revascularization procedure
Time frame: during the trial
vascular death
vascular death
Time frame: during the trial
death from all causes
death from all causes
Time frame: during the trial
combination of primary end-point and TIA
combination of primary end-point and TIA
Time frame: during the trial
revascularization procedures
revascularization procedures
Time frame: during the trial
urgent rehospitalization for ischemic
urgent rehospitalization for ischemic
Time frame: during the trial
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