STAMI.
| Methods | R= randomised but method not stated C = not stated Blinding: patients, clinicians and outcome assessors Patients allocated to indistinguishable blister packs containing either ticlopidine or aspirin | |
| Participants | Multicentre, number not stated 1470 patients randomised > 18 years old with MI (treated with thrombolytic therapy) ≤ 30 days before randomisation Mean age: 59 years Gender: 84% male Race: not stated Comparibility of groups: age, gender, vascular risk factors Ex crit: contraindications to the study drugs including haemopoietic or haemostatic disorders, Hx thrombocytopenia, leucopenia or peptic ulcer, need for oral anticoagulant therapy, scheduled major or bypass surgery, severe co‐morbidity likely to limit life‐expectancy, uncontrolled hypertension, geographic or other factors likely to make participation impractical | |
| Interventions | Ticlopidine 250 mg twice daily versus aspirin 80 mg twice daily | |
| Outcomes | Primary: non‐fatal MI, non‐fatal stroke, angina with objective evidence of cardiac ischaemia, vascular death Secondary: vascular death, non‐vascular death, non‐fatal stroke, non‐fatal MI, angina | |
| Notes | Co: 333 (22.6%) patients permanently discontinued the study drug early; 152 in the aspirin group and 181 in the ticlopidine group Reasons for stopping the treatment early were adverse events (35 in aspirin group and 53 in ticlopidine group) Of these, 26 in the aspirin group and 21 in the ticlopidine group withdrew because of occurrence of a primary end point Duration of follow up: mean follow up was 6 months Lost to follow up: 32 (4.4%) in the ticlopidine group and 30 (4.1%) in the aspirin group | |
B: blood pressure C: concealment of allocation Co: compliance Ex crit: exclusion criteria GI: gastrointestinal Hx: history MI: myocardial infarction R: randomisation method RIND: reversible ischaemic neurological deficit Rx: treatment SAH: subarachnoid haemorrhage TIA: transient ischaemic attack