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

Completed

Phase 3 Results N/A

Trial Description

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 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.

Conditions

Interventions

  • Aspirin (stroke prevention) Drug
    Intervention Desc: Antiplatelet agent; inhibits thromboxane A2
  • Clopidogrel (Plavix®)Drug
    Other Names: Plavix
    Intervention Desc: Antiplatelet agent
  • Warfarin (Coumadin®)Drug
    Other Names: Coumadin; Acenocoumarol
    Intervention Desc: Warfarin
    ARM 1: Kind: Experimental
    Label: Warfarin
    Description: Warfarin
  • Clopidogrel-aspirin Drug
    Other Names: Clopidogrel-aspirin
    Intervention Desc: Clopidogrel-aspirin
    ARM 1: Kind: Experimental
    Label: Clopidogrel-aspirin
    Description: Clopidogrel-aspirin

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Prevention
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients will be randomized to receive either warfarin titrated to yield an international normalized ratio (INR) of 2.0-3.0 or 75-325 mg of aspirin plus 75 mg clopidogrel per day. Patients will be followed by 4 monthly reviews from randomization to the end of the study.

Outcomes

Type Measure Time Frame Safety Issue
Primary Recurrent stroke, acute myocardial infarction, peripheral embolism, vascular death.
Primary New vascular events assessed every 4 months including stroke, myocardial infarction (MI), peripheral events, and vascular death every 4 months Yes
Secondary Recurrent brain infarction during the trial Yes
Secondary brain infarction and transient ischemic attack (TIA) during the studing Yes
Secondary new vascular events and revascularization procedure during the trial Yes
Secondary vascular death during the trial No
Secondary death from all causes during the trial No
Secondary combination of primary end-point and TIA during the trial Yes
Secondary revascularization procedures during the trial Yes
Secondary urgent rehospitalization for ischemic during the trial Yes

Sponsors