Transient Ischemic Attack Clinical Trial
Official title:
Prevention of New Vascular Events in Patients With Brain Infarction or Peripheral Embolism and Thoracic Aortic Plaques ≥ 4 mm in Thickness in the Aortic Arch or Descending Aortic Upstream to the Embolized Artery
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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