A‐STAR 2006.
Methods | RCT Placebo‐controlled, single or double‐blind? Loss to follow‐up reported: no |
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Participants | Symptomatic AF in the previous 6 months Type: paroxysmal or recent onset 95%, persistent 5% (mean duration: NS). n = 431 Men: 62% Age (mean): 62 (SD 10) years Structural heart disease: 69%. LAD: NS. LVEF: NS |
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Interventions | Azimilide 125 mg/day vs placebo Method of AF cardioversion: 100% spontaneous or pharmacological Warfarin discretionary |
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Outcomes | At 6 months: Mortality Adverse effects Proarrhythmia AF recurrence |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Procedure of randomisation not described. |
Allocation concealment (selection bias) | Unclear risk | Method of concealment not described. |
Blinding (performance bias and detection bias) All outcomes | High risk | Placebo‐controlled study, but it was not presented as single or double‐blind. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Few details given on the 61 participants who withdrew from the study. |
Selective reporting (reporting bias) | Low risk | All prespecified outcomes of interest and main outcomes expected were reported. |
Other bias | Low risk | No other bias apparent. |