A Phase 4 interventional study of Prasugrel and Bivalirudin in Myocardial Infarction, sponsored by Deutsches Herzzentrum Muenchen. Status unknown at 3 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-01-07.
Sponsored by Deutsches Herzzentrum Muenchen · Phase 4, Interventional, and Treatment
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.
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.
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's enrollment of 548 is above the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →Deutsches Herzzentrum Muenchen is the lead sponsor of 112 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
60 mg prasugrel plus bivalirudin
Drug: Prasugrel · Drug: Bivalirudin
clopidogrel as loading and heparin
Drug: Clopidogrel · Drug: Heparin
60 mg prasugrel as loading dose prior to PPCI
Also known as: Efient
IV bolus 0.75 mg/kg of body weight followed by an infusion of 1.75 mg/kg/hour during the PPCI
Also known as: Angiox
600 mg clopidogrel as loading dose before PPCI
Also known as: Plavix
i.v. bolus of 70-100 IU/kg body weight
Also known as: unfractionated Heparin
composite of all-cause death, recurrent MI, unplanned IRA revascularization, stroke, definite stent thrombosis or major bleeding
Time frame: 30 days
all-cause death, recurrent MI, unplanned IRA-revascularization, stroke or definite stent thrombosis
Time frame: 30 days
major bleeding complications
Time frame: 30 days
cardiac death
Time frame: 30 days
This study is status unknown, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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Deutsches Herzzentrum Muenchen