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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Desc

Brief Summary:

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.


Detailed Summary:

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.


Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: 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


Original Primary Outcome: New vascular events assessed every 4 months including stroke, MI , peripheral event, and vascular death.

Current Secondary Outcome:

  • 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


Original Secondary Outcome: 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

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: October 6, 2005
Date Started: February 2002
Date Completion:
Last Updated: July 6, 2012
Last Verified: July 2012