ST-segment Elevation Myocardial Infarction Clinical Trial
Official title:
Bivalirudin vs Heparin in NSTEMI and STEMI in Patients on Modern Antiplatelet Therapy in SWEDEHEART A Multicenter, Prospective, Randomized Controlled Clinical Trial Based on the SWEDEHEART Platform
In this trial we test the hypothesis that PCI and bivalirudin is superior to heparin alone (according to local protocol) in reducing death, MI, and major bleeding in patients with NSTEMI or STEMI at 180 days (primary end point), treated with ticagrelor or prasugrel.
The follow up of endpoints will be performed using SWEDEHEART and national registries.
Follow up of primary endpoints and stroke will also be performed by telephone contacts with
the patients or first degree relatives by a nurse phone call after 7 days and 180 days. The
nurses will also accumulate hospital record information on these endpoints.
A central adjudication will be performed for all reported primary endpoints for the first
180 days follow up. Every site will prepare source documents for the event and send it to
UCR for central adjudication by an independent committee.
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