| Methods |
R = randomised, but method not stated
C = not stated
Blinding: described as 'open' (and presumed that neither patients nor investigators blinded) |
| Participants |
Single centre, Germany
January 1979 to January 1983
Peripheral leg arteriopathy with unilateral femoral artery stenosis or occlusion, or the beginning of stenosis of the femoral or popliteal artery on the side opposed to the occlusion
All male (62 men)
Ex crit: thrombocytosis, diabetes, pulmonary insufficiency, thyroid dysfunction, severe hepatic or renal insufficiency, malignant hypertension, acute gastric or recurring ulcers, malignant tumours, or long‐term treatment with drugs modifying platelet functions |
| Interventions |
Ticlopidine 250 mg twice daily versus aspirin 500 mg 3 times daily
Duration of Rx: 2 years |
| Outcomes |
Primary outcome (not included in this review): thrombosis/occlusion of the contralateral femoral artery
Secondary outcomes (included in this review): death, fatal MI, diarrhoea, nausea and gastric pain, skin rash |
| Notes |
Co: withdrawals on ticlopidine: 8 (3 due to adverse drug reaction, 5 other, 0 deaths), withdrawals on aspirin: 23 (11 due to adverse drug reactions, 7 other, 5 deaths)
Follow up: 36 patients (23 ticlopidine, 13 aspirin) completed 2 years in the trial, 27 per protocol (17 ticlopidine, 10 aspirin)
62 patients (31 ticlopidine, 31 aspirin) were analysed by intention to treat, and 44 patients (23 ticlopidine and 21 aspirin) were analysed per protocol, according to the inclusion criteria; the remaining 18 patients (8 ticlopidine and 10 aspirin) had bilateral femoral artery stenosis |
