Aspirin Versus Anticoagulants in Symptomatic Intracranial Stenosis. "AVASIS"

Completed

Phase N/A Results

Trial Description

To compare the safety and efficacy of aspirin and oral anticoagulants in the secondary prevention of vascular events in patients with symptomatic stenosis of the middle cerebral artery (MCA).

Interventions

  • Aspirin (stroke prevention) Drug
    Intervention Desc: Antiplatelet agent; inhibits thromboxane A2
  • Warfarin (Coumadin®)Drug
    Intervention Desc: Anticoagulant (Vitamin K antagonist)

Trial Design

Randomized, comparative, multicenter, parallel, open trial.

Patient Involvement

Prior to enrollment, patients will undergo various blood chemistry tests, evaluation of their international normalized ratio (INR), chest radiography, EKG, transesophageal ECG, at least two types of non-invasive intracranial angiograms (CT-angiography, MR-angiography, or transcranial Doppler angiography), conventional angiography (if indicated), cranial CT or MRI, and will receive MRS, Barthel Index (BI) and National Institutes of Health Stroke Scale (NIHSS) scores. Eligible patients will be randomized to receive either oral anticoagulants (coumarin or warfarin, titrated to yield an INR of 2 - 3) or aspirin 300 mg/day. Patients taking anticoagulants will have their INR monitored monthly for the entire 3-year follow-up period. All patients will be evaluated every 3 months for outcome events, treatment compliance, and adverse effects. Non-invasive angiography will be repeated at 1 year, and blood chemistry labs, MRS, BI, and NIHSS tests will be repeated at 1, 2, and 3 years.

Outcomes

Type Measure Time Frame Safety Issue
Primary Combined endpoint of non-fatal cerebral infarction, non-fatal myocardial infarction (MI), vascular death (cerebral infarction, MI, congestive heart failure, pulmonary thromboembolism, aortic dissection, sudden death), and major hemorrhagic complications.