Aortic Arch Related Cerebral Hazard Trial (ARCH) (ARCH)
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.
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.
|Brain Infarction Transient Ischemic Attack Embolism||Drug: Warfarin Drug: Clopidogrel-aspirin||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|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|
- New vascular events assessed every 4 months including stroke, myocardial infarction (MI), peripheral events, and vascular death [ Time Frame: every 4 months ]New vascular events assessed every 4 months including stroke, myocardial infarction (MI), peripheral events, and vascular death
- Recurrent brain infarction [ Time Frame: during the trial ]Recurrent brain infarction
- brain infarction and transient ischemic attack (TIA) [ Time Frame: during the studing ]brain infarction and transient ischemic attack (TIA)
- new vascular events and revascularization procedure [ Time Frame: during the trial ]new vascular events and revascularization procedure
- vascular death [ Time Frame: during the trial ]vascular death
- death from all causes [ Time Frame: during the trial ]death from all causes
- combination of primary end-point and TIA [ Time Frame: during the trial ]combination of primary end-point and TIA
- revascularization procedures [ Time Frame: during the trial ]revascularization procedures
- urgent rehospitalization for ischemic [ Time Frame: during the trial ]urgent rehospitalization for ischemic
|Study Start Date:||February 2002|
|Study Completion Date:||July 2012|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Warfarin
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00235248
|National Stroke Research Institute-Austin Health|
|Heidelberg Heights, Australia, Vic 3081|
|Bichat Hospital Head of Neurology Department|
|Paris, France, 75018|
|Principal Investigator:||Pierre Amarenco, Pr, MD, PhD||Assistance Publique - Hôpitaux de Paris|