Aortic Arch Related Cerebral Hazard Trial (ARCH) (ARCH)

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:

    • Inclusion within 6 months after onset
    • Duration of symptoms and signs greater than 24 hours
    • Neurological signs at the time of randomization with a Rankin Scale grade 3 or less
    • With normal computed tomography (CT) scan or CT scan showing a brain infarct (even hemorrhagic infarct)
  • 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:

  • Cardiac: endocarditis, atrial fibrillation, intra-cardiac thrombus, valvular prosthesis, rheumatic valvulopathy, left ventricular aneurysm, or ejection fraction less than 25%
  • Atherosclerotic stenosis ipsilateral to the embolic territory: internal carotid artery stenosis greater than 70%, or severe (judgment of the investigator) intracranial stenosis, or scheduled carotid endarterectomy (in that case inclusion is possible 30 days after the procedure)
  • Uncommon causes: dissection, vasculitis, procoagulant state, or sickle cell disease

• Other exclusion criteria:

  • Intercurrent illness with life expectancy less than 36 months
  • Pregnancy and non-menopausal women
  • Unwillingness to participate
  • Poor medication compliance expected
  • Toxicomania
  • Absolute indication for anticoagulant therapy (e.g. atrial fibrillation, intracardiac thrombus, prosthetic valve)
  • Scheduled for carotid endarterectomy (randomization is possible 30 days after endarterectomy)
• 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