Efficacy Study of Combined Prasugrel and Bivalirudin Versus Clopidogrel and Heparin in Myocardial Infarction - Full Text View

Sponsor:	Deutsches Herzzentrum Muenchen
Information provided by:	Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:	NCT00976092

Purpose

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.

Condition	Intervention	Phase
Myocardial Infarction	Drug: Prasugrel Drug: Bivalirudin Drug: Clopidogrel Drug: Heparin	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized Trial of Prasugrel Plus Bivalirudin vs. Clopidogrel Plus Heparin in Patients With Acute STEMI

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners Heart Attack

Drug Information available for: Clopidogrel Clopidogrel Bisulfate Bivalirudin Prasugrel Heparin

U.S. FDA Resources

Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:

composite of all-cause death, recurrent MI, unplanned IRA revascularization, stroke, definite stent thrombosis or major bleeding [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

all-cause death, recurrent MI, unplanned IRA-revascularization, stroke or definite stent thrombosis [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
major bleeding complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
cardiac death [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1240
Study Start Date:	September 2009
Estimated Study Completion Date:	July 2013
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Prasugrel + Bivalirudin: Experimental 60 mg prasugrel plus bivalirudin	Drug: Prasugrel 60 mg prasugrel as loading dose prior to PPCI Drug: Bivalirudin IV bolus 0.75 mg/kg of body weight followed by an infusion of 1.75 mg/kg/hour during the PPCI
Clopidogrel + Heparin: Active Comparator clopidogrel as loading and heparin during PPCI	Drug: Clopidogrel 600 mg clopidogrel as loading dose before PPCI Drug: Heparin i.v. bolus of 100 IE/body weight during PPCI

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients presenting within 24 hours from the onset of symptoms with STEMI
Informed, written consent
In women with childbearing potential a pregnancy test is obligatory.

Exclusion Criteria:

Age < 18 years
Cardiogenic shock
Active bleeding; bleeding diathesis; coagulopathy
History of gastrointestinal or genitourinary bleeding <2 months
Refusal to receive blood transfusion
Major surgery in the last 6 weeks
History of intracranial bleeding or structural abnormalities
Suspected aortic dissection
Heparin-induced thrombocytopenia
Any previous stroke
Prior administration of thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux for the index MI
Known relevant hematological deviations: Hb <100g/l, Thromb. <100x10^9/l
Use of coumadin derivatives within the last 7 days
Chronic therapy with nonsteroidal anti-inflammatory drugs (except aspirin), COX-2 inhibitors, prasugrel or clopidogrel
Known malignancies or other comorbid conditions with life expectancy <1 year
Known severe liver disease, severe renal failure
Known allergy to the study medications
Previous enrollment in this trial
Pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00976092

Contacts

Contact: Julinda Mehilli, MD	+49-89-1218- ext 1534	mehilli@dhm.mhn.de
Contact: Stefanie Schulz, MD	+49-89-1218- ext 1534	schulzs@dhm.mhn.de

Locations

Germany, Bavaria
Deutsches Herzzentrum Muenchen	Recruiting
Munich, Bavaria, Germany, 80636
Contact: Julinda Mehilli, MD +49-89-1218- ext 1534 mehilli@dhm.mhn.de
Contact: Barbara Merzljak +49-89-1218- ext 1534 merzljak@dhm.mhn.de
Principal Investigator: Julinda Mehilli, MD
Klinikum Rechts der Isar, Technische Universitaet Muenchen	Recruiting
Munich, Bavaria, Germany, 81674
Contact: Josef Dirschinger, MD +49-89-4140- ext 2948 dirschinger@med1.med.tu-muenchen.de
Contact: Stefanie Schulz, MD +49-89-1218- ext 1534 schulzs@dhm.mhn.de
Principal Investigator: Josef Dirschinger, MD

Sponsors and Collaborators

Deutsches Herzzentrum Muenchen

Investigators

Principal Investigator:	Julinda Mehilli, MD	Deutsches Herzzentrum Muenchen
Study Chair:	Adnan Kastrati, MD	Deutsches Herzzentrum Muenchen

More Information

No publications provided

Responsible Party:	Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum Muenchen ( Abert Schomig )
Study ID Numbers:	GE IDE I01209
Study First Received:	September 11, 2009
Last Updated:	September 11, 2009
ClinicalTrials.gov Identifier:	NCT00976092 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Deutsches Herzzentrum Muenchen:

myocardial infarction
clopidogrel
prasugrel
bivalirudin
primary PCI

Additional relevant MeSH terms:

Anticoagulants
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Myocardial Ischemia
Heparin, Low-Molecular-Weight
Hematologic Agents
Vascular Diseases
Fibrinolytic Agents
Cardiovascular Agents
Ischemia
Pharmacologic Actions
Calcium heparin

Fibrin Modulating Agents
Necrosis
Pathologic Processes
Therapeutic Uses
Clopidogrel
Bivalirudin
Platelet Aggregation Inhibitors
Cardiovascular Diseases
Infarction
Myocardial Infarction
Heparin

ClinicalTrials.gov processed this record on February 08, 2010