Status:
COMPLETED
Aortic Arch Related Cerebral Hazard Trial (ARCH)
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
National Health and Medical Research Council, Australia
Sanofi
Conditions:
Brain Infarction
Transient Ischemic Attack
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 (ne...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT00235248
Start Date
February 1 2002
End Date
July 1 2012
Last Update
July 10 2012
Active Locations (2)
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1
National Stroke Research Institute-Austin Health
Heidelberg Heights, Australia, Vic 3081
2
Bichat Hospital Head of Neurology Department
Paris, France, 75018