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Aortic Arch Related Cerebral Hazard Trial (ARCH) (ARCH)

This study has been completed.
National Health and Medical Research Council, Australia
Bristol-Myers Squibb
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris Identifier:
First received: October 6, 2005
Last updated: July 6, 2012
Last verified: July 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 Intervention Phase
Brain Infarction
Transient Ischemic Attack
Drug: Warfarin
Drug: Clopidogrel-aspirin
Phase 3

Study Type: Interventional
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

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 ]
    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 ]
    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

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
Drug: Clopidogrel-aspirin
Active Comparator: Warfarin
Drug: 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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:

    • 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
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Please refer to this study by its identifier: NCT00235248

National Stroke Research Institute-Austin Health
Heidelberg Heights, Australia, Vic 3081
Bichat Hospital Head of Neurology Department
Paris, France, 75018
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
National Health and Medical Research Council, Australia
Bristol-Myers Squibb
Principal Investigator: Pierre Amarenco, Pr, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT00235248     History of Changes
Other Study ID Numbers: P991205
Study First Received: October 6, 2005
Last Updated: July 6, 2012

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
Brain Infarction
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents processed this record on May 25, 2017