Brain Infarction, Embolism, Transient Ischemic Attack
Conditions
Keywords
TIA/Brain infarct, and plaque>4mm in the aortic arch, Or peripheral embolism, and plaque>4 mm in the thoracic aorta
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 (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.
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 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.
Interventions
DRUGWarfarin
Warfarin
DRUGClopidogrel-aspirin
Clopidogrel-aspirin
Sponsors
National Health and Medical Research Council, Australia
Sanofi
Bristol-Myers Squibb
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| New vascular events assessed every 4 months including stroke, myocardial infarction (MI), peripheral events, and vascular death | every 4 months | New vascular events assessed every 4 months including stroke, myocardial infarction (MI), peripheral events, and vascular death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| brain infarction and transient ischemic attack (TIA) | during the studing | brain infarction and transient ischemic attack (TIA) |
| new vascular events and revascularization procedure | during the trial | new vascular events and revascularization procedure |
| vascular death | during the trial | vascular death |
| Recurrent brain infarction | during the trial | Recurrent brain infarction |
| combination of primary end-point and TIA | during the trial | combination of primary end-point and TIA |
| revascularization procedures | during the trial | revascularization procedures |
| urgent rehospitalization for ischemic | during the trial | urgent rehospitalization for ischemic |
| death from all causes | during the trial | death from all causes |
Countries
Australia, France
Outcome results
None listed