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 (VALIDATE)

NCT02311231 Phase 4 COMPLETED

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.

Details

Lead sponsor	Uppsala University
Phase	Phase 4
Status	COMPLETED
Enrolment	6012
Start date	2014-06
Completion	2017-03

Conditions

• ST-segment Elevation Myocardial Infarction
• Non ST-segment Elevation Myocardial Infarction

Interventions

• bivalirudin
• Heparin

Primary outcomes

• Death, Myocardial infarction and major bleeding event — 180 days

Countries

Sweden