Randomized trial of immediate anticoagulation of embolic stroke

Terminated

Phase N/A Results

Trial Description

To assess the relative risks and benefits of immediate anticoagulation of cardiogenic embolic stroke.

Interventions

Trial Design

Randomized, unblinded trial of 45 patients at 3 centers.

Patient Involvement

Patients were randomized to receive either immediate heparinization (bolus I.V. infection of 5000-10000 units of heparin followed by continuous infusion at a rate adjusted to prolong the PTT 1.5-2.5 times the pretreatment level) or no anticoagulants for 10 days. Patients in the immediate anticoagulation group in whom long-term anticoagulation with coumadin was planned were required to have at least 48 hours of heparin therapy before receiving coumadin. Heparin was continued in these patients for at least 96 hours but could be discontinued after overlapping with coumadin therapy for more than 24 hours. Patients in the no immediate anticoagulation group in whom long-term anticoagulation with coumadin was planned began coumadin therapy on the 10th day. All patients were evaluated at least every other day.

Outcomes

Type Measure Time Frame Safety Issue
Primary Recurrent embolism, hemorrhagic infarction, death.
Secondary Relative sensitivities of echocardiography, lumbar puncture, and CT in recognizing patients at high risk for early re-embolization and hemorrhagic transformation.