Cairns 1997–CAMIAT.
| Study characteristics | ||
| Methods | Multicentre randomised controlled trial Setting: Survivors of myocardial infarction with frequent or repetitive Ventricular Premature Depolarizations Country: Canada |
|
| Participants | N = 1202 (606 amiodarone, 596 placebo) Sex: 82% male Age: mean 64 years Inclusion: ≥ 7 days post acute MI (primary prevention) |
|
| Interventions | Group 1: amiodarone 10 mg/kg/d the first 2 weeks then 200‐400 mg/d (final dose) Group 2: placebo Duration: 2 years |
|
| Outcomes | All‐cause mortality, cardiac mortality, SCD | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: ". . . according to the computer generated randomisation code (stratified by centre in blocks of four) prepared by the External Safety and Efficacy Monitoring Committee. . ." |
| Allocation concealment (selection bias) | Low risk | Quote: "The complete randomisation code was available only to the chair of the External Safety and Efficacy Monitoring Committee. Thus, standard masked conditions were extended to include the Steering Committee, the External Safety and Efficacy Monitoring Committee, the Coordinating and Methods Centre, and Sanofi Winthrop, all of whom were unaware of treatment allocation." |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "An independent company was contracted to pack the active drug (amiodarone 200 mg tablets) and matching placebo tablets." |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The outcome events reported by the clinical investigators were all reviewed by the External Validation Committee under masked conditions. This committee had final responsibility for the verification of resuscitated ventricular fibrillation and the classification of deaths." |
| Incomplete outcome data (attrition bias) Objective outcomes (death) | Low risk | Quote: "[A]ll outcomes were also analysed by the intention‐to‐treat principle, in which all patients were judged to be at risk from the time of enrollment until the predefined completion of follow‐up, irrespective of whether the study drug was discontinued." Quote: ". . . intention‐to‐treat analyses included all randomised patients. . ." |
| Incomplete outcome data (attrition bias) Subjective outcomes (quality of life) | Unclear risk | No description regarding any aspect of any subjective outcome was made |
| Selective reporting (reporting bias) | Low risk | The study protocol was not available, but it is clear that the published report includes all expected outcomes |
| Other bias | Low risk | The study appears to be free of other sources of bias |