Status:
COMPLETED
Bivalirudin vs Heparin in NSTEMI and STEMI in Patients on Modern Antiplatelet Therapy in SWEDEHEART
Lead Sponsor:
Uppsala University
Collaborating Sponsors:
Lund University
Conditions:
ST-segment Elevation Myocardial Infarction
Non ST-segment Elevation Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 1...
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...
Eligibility Criteria
Inclusion
- Patients with a diagnosis of NSTEMI as judged by the physician in accordance with current guideline definitions (positive troponin) or, patients with a diagnosis of STEMI as defined by chest pain suggestive for myocardial ischemia for at least 30 minutes before hospital admission, time from onset of symptoms of less than 24 hours, and an ECG with new ST-segment elevation in two or more contiguous leads of ≥0.2 mV in leads V2-V3 and/or ≥0.1 mV in other leads or a probable new-onset left bundle branch block.
- PCI of culprit lesion is intended (therapeutic PCI, not primarily diagnostic PCI).
- Treated with bolus dose of ticagrelor or prasugrel before start of PCI. See 2.6
- Ability to provide informed consent
- Age 18 years or older
Exclusion
- Previous randomization in the VALIDATE-SWEDEHEART trial.
- Known terminal disease with life expectancy less than one year.
- Patients with known ongoing bleeding
- Patients with uncontrolled hypertension in the opinion of the investigator
- Patients with known subacute bacterial endocarditis
- Patients with known severe renal (GFR \< 30 ml/min) and/or liver dysfunction
- Patients with known thrombocytopenia or thrombocyte function defects
- Any other contraindication for the study medications.
- Heparin \> 5000U Before arriving to PCI lab or \> 3000 U given during angiography before randomization.
- GpIIb/IIIa inhibitors have been given or are pre-planned to be given during the procedure.
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2017
Estimated Enrollment :
6012 Patients enrolled
Trial Details
Trial ID
NCT02311231
Start Date
June 1 2014
End Date
March 1 2017
Last Update
May 19 2017
Active Locations (1)
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1
Lund University
Lund, Sweden, 221 85