Aortic Arch Related Cerebral Hazard Trial (ARCH)

This study has been completed.
Sponsor:
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

October 6, 2005
July 6, 2012
February 2002
December 2010   (final data collection date for primary outcome measure)
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
New vascular events assessed every 4 months including stroke, MI , peripheral event, and vascular death.
Complete list of historical versions of study NCT00235248 on ClinicalTrials.gov Archive Site
  • 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
Recurrent brain infarction,brain infarction and TIA,new vascular event and revascularization procvedure,vascular death,death from all causes ,combination of primary end-point and TIA,revascularization procedures,urgent rehopitalization for ischemic
Not Provided
Not Provided
 
Aortic Arch Related Cerebral Hazard Trial (ARCH)
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Brain Infarction
  • Transient Ischemic Attack
  • Embolism
  • Drug: Warfarin
    Warfarin
    Other Name: Warfarin
  • Drug: Clopidogrel-aspirin
    Clopidogrel-aspirin
    Other Name: Clopidogrel-aspirin
  • Experimental: Clopidogrel-aspirin
    Clopidogrel-aspirin
    Intervention: Drug: Clopidogrel-aspirin
  • Active Comparator: Warfarin
    Warfarin
    Intervention: Drug: Warfarin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
350
July 2012
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   France
 
NCT00235248
P991205
Yes
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
  • National Health and Medical Research Council, Australia
  • Sanofi
  • Bristol-Myers Squibb
Principal Investigator: Pierre Amarenco, Pr, MD, PhD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP