Aspirin and sulfinpyrazone in threatened stroke

Completed

Phase N/A Results

Trial Description

To determine whether aspirin or sulfinpyrazone, singly or in combination, influence the subsequent occurrence of continuing transient ischemic attacks, stroke or death.

Interventions

  • Aspirin (stroke prevention) Drug
    Intervention Desc: Antiplatelet agent; inhibits thromboxane A2
  • Sulfinpyrazone (Anturane)Drug
    Intervention Desc: Uricosuric agent, platelet inhibitor, antithrombotic agent.

Trial Design

Double-blind, randomized, stratified trial of 585 patients at 24 Canadian centers.

Patient Involvement

Patients were stratified according to the presumed site of ischemia and the presence or absence of a residual deficit and were then randomized to one of four treatment regimens: 1) 200 mg of sulfinpyrazone plus placebo 2) placebo plus 325 mg of acetylsalicylic acid 3) both active drugs 4) both placebo. The pills in each regimen were taken four times daily. Patients were evaluated after 1 and 3 months of treatment and every 3 months thereafter for an average of 26 months.

Outcomes

Type Measure Time Frame Safety Issue
Primary Subsequent occurrence of continuing transient ischemic attacks, stroke or death. All events occurring in the first week of treatment were excluded due to allow sufficient time for sulfinpyrazone to produce a biologically appreciable effect. Events occurring within the first 6 months of withdrawal from the trial were included to prevent bias.
Secondary Relative efficacy of drugs among clinical subgroups.

Sponsors

Medical Research Council of Canada