SMART 2002.
Methods | RCT Double‐blind Loss to follow‐up reported: no |
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Participants | Symptomatic paroxysmal AF having > 1 episode monthly (59%) or persistent AF lasting < 1 month (41%). n = 94 Men: 72% Age (mean): 60 (SD 12) years Structural heart disease: NS. LAD: NS. LVEF: NS |
|
Interventions | Aprindine 40 mg/day vs placebo Method of AF cardioversion: pharmacological 50%, electrical 50% Warfarin discretionary |
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Outcomes | At 6 months: Mortality Proarrhythmia Adverse effects AF recurrence |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation list. |
Allocation concealment (selection bias) | Low risk | Central allocation, after inclusion, using a randomisation list common to all centres. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Double‐blind study. Matching placebo capsules and tablets identical in size, weight, colour and taste. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Withdrawals well described but unclear whether additional participants were lost to follow‐up. |
Selective reporting (reporting bias) | Low risk | All prespecified outcomes were reported in the prespecified manner. |
Other bias | Low risk | No other bias apparent. |