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Sponsors and Collaborators: |
Assistance Publique - Hôpitaux de Paris National Health and Medical Research Council, Australia Sanofi-Aventis Bristol-Myers Squibb |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00235248 |
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.
Condition | Intervention | Phase |
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Brain Infarction Transient Ischemic Attack Embolism |
Drug: Clopidogrel + aspirin |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 650 |
Study Start Date: | February 2002 |
Estimated Study Completion Date: | October 2008 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts 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:
Non-disabling brain infarcts:
Exclusion Criteria:
Other causes of embolism:
Other exclusion criteria:
Contact: Pierre Amarenco, Pr, MD, PhD | +33(0)-140258726 | pierre.amarenco@bch.aphp.fr |
Australia | |
National Stroke Research Institute-Austin Health | Recruiting |
Heidelberg Heights, Australia, Vic 3081 | |
Contact: Geoffrey A. Donnan, Pr, MD, PhD 613-9496-2699 gdonnan@unimelb.edu.au | |
Contact: Anna Marcon amarcon@nsri.org.au | |
France | |
Bichat Hospital Head of Neurology Department | Recruiting |
Paris, France, 75018 | |
Contact: Pierre Amarenco, Pr, MD, PhD +33(0)-1 40258726 pierre.amarenco@bch.aphp.fr |
Principal Investigator: | Pierre Amarenco, Pr, MD, PhD | Assistance Publique - Hôpitaux de Paris |
Study ID Numbers: | P991205, AOM97211 |
Study First Received: | October 6, 2005 |
Last Updated: | March 14, 2007 |
ClinicalTrials.gov Identifier: | NCT00235248 History of Changes |
Health Authority: | France: Ministry of Health |
TIA/Brain infarct and plaque>4mm in the aortic arch Or peripheral embolism and plaque>4 mm in the thoracic aorta |
Ischemic Attack, Transient Cerebral Infarction Stroke Vascular Diseases Central Nervous System Diseases Ischemia Brain Diseases Cerebrovascular Disorders Thrombosis |
Embolism and Thrombosis Necrosis Aspirin Embolism Clopidogrel Brain Ischemia Platelet Aggregation Inhibitors Brain Infarction Infarction |
Ischemic Attack, Transient Hematologic Agents Stroke Nervous System Diseases Vascular Diseases Central Nervous System Diseases Ischemia Brain Diseases Cerebrovascular Disorders Pharmacologic Actions Necrosis |
Embolism and Thrombosis Pathologic Processes Embolism Therapeutic Uses Clopidogrel Brain Ischemia Platelet Aggregation Inhibitors Cardiovascular Diseases Brain Infarction Infarction |