Efficacy Study of Combined Prasugrel and Bivalirudin Versus Clopidogrel and Heparin in Myocardial Infarction
Information source: Deutsches Herzzentrum Muenchen
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Myocardial Infarction
Intervention: Prasugrel (Drug); Bivalirudin (Drug); Clopidogrel (Drug); Heparin (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Deutsches Herzzentrum Muenchen Official(s) and/or principal investigator(s): Julinda Mehilli, MD, Principal Investigator, Affiliation: Deutsches Herzzentrum Muenchen Adnan Kastrati, MD, Study Chair, Affiliation: Deutsches Herzzentrum Muenchen
Summary
Randomized comparison of two different anticoagulation strategies: prasugrel plus
bivalirudin versus clopidogrel plus heparin in patients with acute myocardial infarction
undergoing emergency catheterization and coronary intervention.
Clinical Details
Official title: Randomized Trial of Prasugrel Plus Bivalirudin vs. Clopidogrel Plus Heparin in Patients With Acute STEMI
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: composite of all-cause death, recurrent MI, unplanned IRA revascularization, stroke, definite stent thrombosis or major bleeding
Secondary outcome: all-cause death, recurrent MI, unplanned IRA-revascularization, stroke or definite stent thrombosismajor bleeding complications cardiac death
Detailed description:
Primary percutaneous coronary intervention (PPCI) is the preferred reperfusion strategy for
patients with acute ST-segment elevation myocardial infarction (STEMI). Additional
anticoagulation therapy prior or during intervention plays an important role in the short-
and long-term outcomes after PPCI. Two separate studies have shown significant benefit
against conventional therapy based on clopidogrel and heparin for two recently approved
drugs: the direct thrombin inhibitor bivalirudin and the thienopyridine prasugrel. In the
HORIZONS-AMI trial, bivalirudin after pretreatment with clopidogrel resulted in improved net
clinical outcomes. However, during the first 24 hours after PPCI an increase in the stent
thrombosis rate was observed with bivalirudin therapy. Prasugrel has been shown to be
superior to clopidogrel in patients with acute coronary syndromes undergoing PCI. The
benefit in reduction of ischemic complication was even greater in the subset of patients
with STEMI without any increase in the bleeding risk and with a significant reduction in the
stent thrombosis rate. Expectedly, the synergic actions of prasugrel and bivalirudin may
maximize the benefit of antithrombotic therapy for STEMI patients undergoing PPCI.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Patients presenting within 24 hours from the onset of symptoms with STEMI
2. Informed, written consent
3. In women with childbearing potential a pregnancy test is obligatory.
Exclusion Criteria:
1. Age < 18 years
2. Cardiogenic shock
3. Active bleeding; bleeding diathesis; coagulopathy
4. History of gastrointestinal or genitourinary bleeding <2 months
5. Refusal to receive blood transfusion
6. Major surgery in the last 6 weeks
7. History of intracranial bleeding or structural abnormalities
8. Suspected aortic dissection
9. Heparin-induced thrombocytopenia
10. Any previous stroke
11. Prior administration of thrombolytics, bivalirudin, low-molecular weight heparin or
fondaparinux for the index MI
12. Known relevant hematological deviations: Hb <100g/l, Thromb. <100x10^9/l
13. Use of coumadin derivatives within the last 7 days
14. Chronic therapy with nonsteroidal anti-inflammatory drugs (except aspirin), COX-2
inhibitors, prasugrel
15. Known malignancies or other comorbid conditions with life expectancy <1 year
16. Known severe liver disease, severe renal failure
17. Known allergy to the study medications
18. Previous enrollment in this trial
19. Pregnancy
Locations and Contacts
Herzzentrum der Segeberger Kliniken, Bad Segeberg 23795, Germany
Deutsches Herzzentrum Muenchen, Munich, Bavaria 80636, Germany
Klinikum rechts der Isar, Technische Universitaet Muenchen, Munich, Bavaria 81674, Germany
Additional Information
Starting date: September 2009
Last updated: January 6, 2014
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