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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6,012
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.
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
Lund University
Lund, Sweden
Death, Myocardial infarction and major bleeding event
Time frame: 180 days
Death, Myocardial infarction and major bleeding events in the subgroups NSTEMI and STEMI
Time frame: 180 days
Time to primary endpoints (death, myocardial infarction and major bleeding event)
Time to individual components of the primary end point (death, myocardial infarction and major bleeding).
Time frame: 180 days
Number of events where primary endpoints (death, myocardial infarction and major bleeding event) and stroke have been registered
The primary end point combined with stroke as reported in the Swedish national patient registry.
Time frame: 180 days
Number of events where primary endpoints (death, myocardial infarction and major bleeding event) have been registered in heparin subgroups (U/kg, groups with certain max ACT values etc)
Time frame: 180 days
TIMI flow grade after PCI
Time frame: 180 days
Time to re-hospitalization with reinfarction
Time to re-hospitalization with reinfarction as reported in Swedeheart
Time frame: 180 days
Time to all-cause death or re-hospitalization with myocardial infarction
Time frame: 180 days
Time to target vessel revascularization
Time to target vessel revascularization as reported in SWEDEHEART.
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Time frame: 180 days
Time to target lesion revascularization
Time to target lesion revascularization as reported in SWEDEHEART
Time frame: 180 days
Time to stent thrombosis
Time to stent thrombosis as reported in SWEDEHEART.
Time frame: 180 days
Time to restenosis
Time to restenosis as reported in SWEDEHEART.
Time frame: 180 days
Time to re-hospitalization with heart failure
Time to re-hospitalization with heart failure as reported in SWEDEHEART.
Time frame: 180 days
Heart failure and complications of PCI during index hospitalization
Heart failure and complications of PCI during index hospitalization as reported in SWEDEHEART
Time frame: 180 days
Minor bleeding during index hospitalization
Minor bleeding during index hospitalization as reported in SWEDEHEART
Time frame: 180 days
Length of index hospital stay
Length of index hospital stay as reported in SWEDEHEART
Time frame: 180 days
Bail-out use of GpIIb/IIIa
Bail-out use of GpIIb/IIIa inhibitors during PCI
Time frame: 180 days