Table 1.
Trial | Patient characteristics | Intervention (months of follow up) | INR | Random allocation | Blinding used | Withdrawals from trial (warfarin/antiplatelet) |
---|---|---|---|---|---|---|
AFASAK 115 | Chronic non-rheumatic atrial fibrillation, no stroke in prevoius month but 5.5% had previous TIA/stroke, BP <180/100 mm Hg; n=671, mean (range) age 73 (38-91) years | Aspirin 75 mg v warfarin (24) | 2.8-4.2 | Drug packages sequenced randomly by computer; concealment of allocation may be inadequate | Outcomes not assessed or reviewed blind to treatment; statistician blinded | 38% (126) v 13% (44) |
SPAF II <7517 | Non-rheumatic atrial fibrillation ⩾12 months. No TIA/stroke in previous 2 years but 7% had previous TIA/stroke, n=715, all patients <75, mean (SD) 64 (8) years | Aspirin 325 mg v warfarin (36) | 2-4.5 | Computerised randomisation performed in each centre; concealment adequate | Outcomes reviewed blind; not stated for statistician | Withdrawals not reported but only 0.8 % (3) v 0.3% (1) lost to follow up (<0.4% overall) |
SPAF II 75+17 | As SPAF II <75 but all aged ⩾75 years, n=385, mean (SD) 80 (3) years | Aspirin 325 mg v warfarin (24) | 2.4-4.5 | Computerised randomisation performed in each centre; concealment adequate | Outcomes reviewed blind; not stated for statistician | Withdrawals not reported; no losses to follow up |
AFASAK 216 | Non-rheumatic atrial fibrillation, third <1 year duration, 70% diagnosed heart failure, 8% past TIA/stroke, 8% history of MI, n=239, mean (SD) age 73 (7) years | Aspirin 300 mg v warfarin (42) | 2.0-3.0 | Computerised randomisation performed; concealment adequate | Outcomes reviewed blind; not stated for statistician | Overall 16.5% withdrawn and 8.6% dropped out, but not broken down by treatment allocation; losses to follow up not reported |
SIFA18 | Non-rheumatic atrial fibrillation or paroxysmal AF, 50% had previous TIA/stroke, n=916, mean (SD) age 73 (8) years | Indoprofen 400 mg v warfarin (12) | 2-3.5 | Computerised dial up telephone randomisation service; concealment adequate | Outcomes reviewed blind; not stated for statistician | 10.6% (48) v 9.1% (42) |
PATAF19 | Non-rheumatic atrial fibrillation or paroxysmal AF drawn from primary care, 9% had history of MI, n=272, mean (SD) age 75 (7.5) years | Aspirin 150 mg v warfarin (31) | 2.5-3.5 | Computerised dial up telephone randomisation service; concealment adequate | Outcomes reviewed blind; not stated for statistician | No losses to follow up |
INR=international normalised ratio, MI=myocardial infarction, TIA=transient ischaemic attack, AF=atrial fibrillation.