ASPECT-2
Antithrombotics in the Secondary Prevention of Events in Coronary Thrombosis-2
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Status:
Trial complete. Results published in July of 2002.
Purpose:
To determine the long term efficacy of aspirin and oral anticoagulants in reducing ischemic events after acute coronary events.
Year Finished:
2001
Design:
Prospective, multicenter, randomized open-label trial.
Inclusion Criteria
Men and non-pregnant women with acute myocardial infarction or unstable angina within 8 weeks of onset.
Exclusion Criteria
Patients with contraindictions for the study drug, planned revascularization procedure, serious comorbidity, increased risk of bleeding, abnormal blood platelets, anaemia, history of stroke.
Patient Involvement:
Patients were randomized into 3 groups to receive either aspirin (80 mg) (n=336), oral anticoagulants (target INR 3.0-4.0) (n=325) or oral anticoagulants (target INR 2.0-2.50 plus aspirin (80 mg) (n=332). An assessment questionnaire was completed every 3 months.
Primary Outcome:
Death, time to myocardial infarction or stroke.
Secondary Outcome:
Death from all causes, episodes of bleeding.
Results:
The primary endpoint was reached in 9% patients on aspirin, 5% on anticoagulants (p=0.0479), and 5% on combination therapy (p=0.03). Major bleeding was recorded in 3 patients on aspirin, 3 on anticoagulants (p=1.0), and 7 on combination therapy (p=0.2). Minor bleeding was significanty higher in patients using the combination therapy.
Source of Information:
The Lancet 2002; 360:110-113
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This information last updated on: 5/1/2003
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