Aortic Arch Related Cerebral Hazard Trial (ARCH) (ARCH)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00235248|
Recruitment Status : Completed
First Posted : October 10, 2005
Last Update Posted : July 10, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain Infarction Transient Ischemic Attack Embolism||Drug: Warfarin Drug: Clopidogrel-aspirin||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||February 2002|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||July 2012|
Active Comparator: Warfarin
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|