NCT02311231

Bivalirudin vs Heparin in NSTEMI and STEMI in Patients on Modern Antiplatelet Therapy in SWEDEHEART

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 6,012 (actual)
• Sponsor: Uppsala University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	bivalirudin	Will be administered as an intravenous bolus of 0.75 mg per kilogram, followed by an infusion of 1.75 mg per kilogram per hour). Bivalirudin will be administered alone or with a low dose of heparin up to 3000U heparin in lab or up to 5000 U given pre-hospital according to local practice.
DRUG	Heparin	Treatment with unfractionated Heparin 5000 IU/ml i.v. ,Leo Pharma, Sweden, (the control group). Heparin in the control group is administered as an intravenous or intra-arterial bolus according to local practice. A dose of 70-100 U/kg is recommended

Timeline

• Start date: 2014-06-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2014-12-08
• Last updated: 2017-05-19

Locations

1 site across 1 country: Sweden