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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.
Full description
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.
Enrollment
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Volunteers
Inclusion criteria
Patients of both sexes aged ≥ 18 years with the following 4 inclusion criteria:
One of the 3 following ischemic events in the preceding 6 months:
Transient ischemic attack (TIA)
Non-disabling brain infarcts:
Peripheral embolism
Atherosclerotic plaque in the thoracic aorta is defined as wall thickness ≥ 4 mm where the protruding material is the largest, measured at transesophageal echocardiography with multiplane transducer or a plaque less than 4 mm but with mobile component.
Informed consent signed
Life expectancy > 3 years
Exclusion criteria
Other causes of embolism:
Other exclusion criteria:
CT scan with an intracranial lesion other than brain infarction (space occupying mass, intracranial hemorrhage)
Transesophageal echocardiography (TEE) with plaque ≥ 4 mm in thickness distal to the supposed embolized artery (judgement of the investigator).
Contraindication to clopidogrel, aspirin, and oral anticoagulants
Primary purpose
Allocation
Interventional model
Masking
350 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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