MASTER DAPT was a global randomized-controlled trial to evaluate the appropriate duration of dual antiplatelet therapy in patients with coronary artery disease at high risk for bleeding.
One month after they had undergone implantation of a stent for coronary heart disease, 4,579 patients at high bleeding risk were randomized to either discontinue dual antiplatelet therapy immediately (abbreviated therapy) or to continue it for at least two additional months (standard therapy). One month of dual antiplatelet therapy was non-inferior to the continuation of therapy for at least two additional months with regard to the occurrence of net adverse clinical events and major adverse cardiac or cerebral events; abbreviated therapy also resulted in a lower incidence of major or clinically relevant nonmajor bleeding.
The project in selected numbers:
- 142 trial sites with 820 users
- Electronic Case Report Form: 1671 Variables à 78 forms à 7 visits; 3,780 rules, conditions, or automatic checks implemented
- 166,005 forms completed
- 54,048 queries generated
CTU Bern was involved in the planning phase of the trial and contributed to the trial design and protocol.
CTU Bern set up the study in the secuTrial database and maintained the database during the study.
Central Data Monitoring
CTU Bern monitored database entries during the course of the study and ensured data quality.
All main analyses were done at CTU Bern.