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


Phase 3 Results N/A

Eligibility Criteria

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