Higher vs lower heparin dosing for elective PCI tested in cluster randomized trial design

This is a trial design and rationale paper for a cluster randomized crossover trial. The study will compare hospital-level policies of higher-dose (100 units/kg) versus lower-dose (70 units/kg) unfractionated heparin dosing in patients undergoing elective percutaneous coronary intervention (PCI). The trial will be conducted across 11 centers in Ontario, Canada.

The primary outcome is a composite of all-cause death, myocardial infarction, or target vessel revascularization within 30 days of the index PCI. Secondary outcomes include major bleeding within 30 days and a composite of the primary outcome plus major bleeding. The follow-up period is 30 days.

No efficacy or safety results are reported, as this publication describes the trial's design and rationale. The main results, including effect sizes, absolute numbers, and p-values or confidence intervals for the primary and secondary outcomes, are not available. Safety data on adverse events, serious adverse events, and tolerability are also not reported.

Key limitations are not reported in this design paper. The practice relevance and funding or conflicts of interest are not reported. As this is a design paper, the clinical implications are pending the trial's completion and the reporting of its results.