From: Heterogeneity in pragmatic randomised trials: sources and management
Patients: Adults with ST-segment elevation myocardial infarction Centres: 29 Swedish centres and 1 Icelandic coronary intervention centre Intervention: Thrombus aspiration followed by percutaneous coronary intervention Control: Percutaneous coronary intervention Outcome: All-cause mortality at 30 days (see below) Design: Two parallel-group individually randomised trial within cohort | |
Outcome | “Data on mortality obtained from the national population registry”. “The concept of a trial design using a national registry as the basis for continuous enrolment and randomisation of all-comers is potentially limited by the lack of formal central adjudication of clinical events. Therefore, we have chosen all-cause mortality from the national complete mortality registry as the primary end point of the trial.” |