Aortic Arch Related Cerebral Hazard Trial (ARCH)
This study has been completed.
Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborators:
National Health and Medical Research Council, Australia
Sanofi
Bristol-Myers Squibb
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00235248
First received: October 6, 2005
Last updated: July 6, 2012
Last verified: July 2012
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Purpose
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 |
|---|---|---|
|
Brain Infarction Transient Ischemic Attack Embolism |
Drug: Warfarin Drug: Clopidogrel-aspirin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study 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 |
Resource links provided by NLM:
Further study details as provided by Assistance Publique - Hôpitaux de Paris:
Primary Outcome Measures:
- New vascular events assessed every 4 months including stroke, myocardial infarction (MI), peripheral events, and vascular death [ Time Frame: every 4 months ] [ Designated as safety issue: Yes ]New vascular events assessed every 4 months including stroke, myocardial infarction (MI), peripheral events, and vascular death
Secondary Outcome Measures:
- Recurrent brain infarction [ Time Frame: during the trial ] [ Designated as safety issue: Yes ]Recurrent brain infarction
- brain infarction and transient ischemic attack (TIA) [ Time Frame: during the studing ] [ Designated as safety issue: Yes ]brain infarction and transient ischemic attack (TIA)
- new vascular events and revascularization procedure [ Time Frame: during the trial ] [ Designated as safety issue: Yes ]new vascular events and revascularization procedure
- vascular death [ Time Frame: during the trial ] [ Designated as safety issue: No ]vascular death
- death from all causes [ Time Frame: during the trial ] [ Designated as safety issue: No ]death from all causes
- combination of primary end-point and TIA [ Time Frame: during the trial ] [ Designated as safety issue: Yes ]combination of primary end-point and TIA
- revascularization procedures [ Time Frame: during the trial ] [ Designated as safety issue: Yes ]revascularization procedures
- urgent rehospitalization for ischemic [ Time Frame: during the trial ] [ Designated as safety issue: Yes ]urgent rehospitalization for ischemic
| Enrollment: | 350 |
| Study Start Date: | February 2002 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Clopidogrel-aspirin
Clopidogrel-aspirin
|
Drug: Clopidogrel-aspirin
Clopidogrel-aspirin
Other Name: Clopidogrel-aspirin
|
|
Active Comparator: Warfarin
Warfarin
|
Drug: Warfarin
Warfarin
Other Name: Warfarin
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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 exclusion criteria:
- Intercurrent illness with life expectancy less than 36 months
- Pregnancy and non-menopausal women
- Unwillingness to participate
- Poor medication compliance expected
- Toxicomania
- Absolute indication for anticoagulant therapy (e.g. atrial fibrillation, intracardiac thrombus, prosthetic valve)
- Scheduled for carotid endarterectomy (randomization is possible 30 days after endarterectomy)
- CT scan with an intracranial lesion other than brain infarction (space occupying mass, intracranial hemorrhage)
- Transesophageal echocardiography (TEE) with plaque ≥ 4 mm in thickness distal to the supposed embolized artery (judgement of the investigator).
- Contraindication to clopidogrel, aspirin, and oral anticoagulants
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00235248
Locations
| Australia | |
| National Stroke Research Institute-Austin Health | |
| Heidelberg Heights, Australia, Vic 3081 | |
| France | |
| Bichat Hospital Head of Neurology Department | |
| Paris, France, 75018 | |
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
National Health and Medical Research Council, Australia
Sanofi
Bristol-Myers Squibb
Investigators
| Principal Investigator: | Pierre Amarenco, Pr, MD, PhD | Assistance Publique - Hôpitaux de Paris |
More Information
No publications provided
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00235248 History of Changes |
| Other Study ID Numbers: | P991205 |
| Study First Received: | October 6, 2005 |
| Last Updated: | July 6, 2012 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
TIA/Brain infarct and plaque>4mm in the aortic arch Or peripheral embolism and plaque>4 mm in the thoracic aorta |
Additional relevant MeSH terms:
|
Ischemic Attack, Transient Embolism Infarction Brain Infarction Brain Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Embolism and Thrombosis Ischemia Pathologic Processes Necrosis |
Stroke Aspirin Ticlopidine Clopidogrel Warfarin Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 16, 2013