Current partner codePEPTIDESDE
NCT00976092·Phase 4·INTERVENTIONAL

Efficacy Study of Combined Prasugrel and Bivalirudin Versus Clopidogrel and Heparin in Myocardial Infarction

Status

Unknown

Phase

Phase 4

Enrollment

548

Locations

3

Results

Not posted

Publications

2

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

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

DRUG

Clopidogrel

600 mg clopidogrel as loading dose before PPCI

DRUG

Heparin

i.v. bolus of 70-100 IU/kg body weight

Timeline

From registration to results.

  1. First posted

    Sep 14, 2009

  2. Study start

    Sep 2009

  3. Primary completion

    Feb 2014

  4. Study completion

    Feb 2015

  5. Results posted

    Not reported

  6. Registry updated

    Jan 7, 2014

Outcomes

What the study measures.

Primary outcomes

composite of all-cause death, recurrent MI, unplanned IRA revascularization, stroke, definite stent thrombosis or major bleeding

Time frame · 30 days

Secondary outcomes

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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

Study locations

3 registered sites.

Germany. Showing up to 24 locations stored in the fast local snapshot.

Deutsches Herzzentrum Muenchen

Munich, Bavaria, Germany

Klinikum rechts der Isar, Technische Universitaet Muenchen

Munich, Bavaria, Germany

Herzzentrum der Segeberger Kliniken

Bad Segeberg, Germany

Related trials

More studies on Bivalirudin.

Related PeptideStat pages

Put the record in context.

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