COMMANDER HF 2018.
| Study characteristics | ||
| Methods | Randomised, controlled, double‐blind trial | |
| Participants | Heart failure, sinus rhythm, coronary artery disease; N = 5022 | |
| Interventions | Rivaroxaban versus placebo | |
| Outcomes | The primary efficacy outcome was the composite of death from any cause, myocardial infarction, or stroke. Secondary efficacy outcomes included death from cardiovascular causes, re‐hospitalisation for decompensation of HF, rehospitalization for cardiovascular events, and the composite of death from cardiovascular causes or re‐hospitalisation for decompensation of HF. |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Participants were randomised using an interactive web response system and permuted blocks of four. |
| Allocation concealment (selection bias) | Low risk | Participants were randomised using an interactive web response system and permuted blocks of four. |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind study |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcomes were confirmed by investigators using an extensive, dedicated case‐report form, with source‐data verification by the sponsor’s clinical operations team. |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | In total, 244 participants did not complete the study, were lost to follow‐up, withdrew consent, or had other reasons. |
| Selective reporting (reporting bias) | Low risk | The results of the study showed that treatment had no effect on outcome, thus this was therefore a negative study. |