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Bivalirudin/Prasugrel Versus Abciximab/Clopidogrel in Patients Presenting With STEMI

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2010 by Istituto Clinico Sant'Ambrogio.
Recruitment status was:  Not yet recruiting
Centro Cardiologico Monzino
Azienda Ospedaliera Niguarda Cà Granda
Istituto Clinico Humanitas
Information provided by:
Istituto Clinico Sant'Ambrogio Identifier:
First received: June 25, 2010
Last updated: July 7, 2010
Last verified: June 2010
In the setting of ST elevation myocardial infarction newer therapies has been recently studied and, following encouraging results, introduced into the clinical practice. Prasugrel showed to be a valid alternative to overcome limitation of clopidogrel therefore providing a better ischemic protection. On the other hand, bivalirudin is at least as beneficial as heparin/abciximab as anticoagulant agent but associated with fewer hemorrhagic events. The primary hypothesis of the study is that the combination of prasugrel plus bivalirudin can be associated with a better risk/benefit profile.

Condition Intervention Phase
ST-Elevation Myocardial Infarction Primary Percutaneous Coronary Intervention Drug: prasugrel/bivalirudin Drug: clopidogrel/abciximab Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bivalirudin Plus Prasugrel vs Abciximab Plus Clopidogrel. Optimizing Ischemic Protection and Bleeding Risk in Patients With ST Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

Resource links provided by NLM:

Further study details as provided by Istituto Clinico Sant'Ambrogio:

Primary Outcome Measures:
  • major adverse cardiovascular events [ Time Frame: 1 year ]
    Combined outcome of overall death, non fatal MI, major stroke

Secondary Outcome Measures:
  • major bleedings [ Time Frame: 1 year ]
    according to TIMI major bleedings definition

  • minor bleedings [ Time Frame: 1 year ]
    according to TIMI minor bleedings definition

  • stent thrombosis [ Time Frame: 1 year ]
    according to ARC definition of probable/definite stent thrombosis

  • overall death [ Time Frame: 1 year ]
  • non fatal myocardial infarction [ Time Frame: 1 year ]
    defined according to current guidelines

  • ischemic stroke [ Time Frame: 1 year ]

Estimated Enrollment: 800
Study Start Date: August 2010
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: prasugrel/bivalirudin
60 mg loading dose of prasugrel will be followed by maintenance dose of 10mg (or 5mg according to body weight and age). During primary PCI, Bivalirudin will be used as anticoagulant (bolus plus infusion), on a weight-adjusted dose.
Drug: prasugrel/bivalirudin
60mg loading dose followed by 10mg or 5 mg (according to body weight or age)maintenance dose of prasugrel. Bivalirudin during the primary PCI (bolus plus infusion)
Other Names:
  • Efient
  • Angiox
Active Comparator: clopidogrel/abciximab
600mg loading dose of clopidogrel will be followed by 75mg maintenance dose. During primary PCI abciximab (bolus plus infusion) will be used as anticoagulant.
Drug: clopidogrel/abciximab
600mg loading dose of clopidogrel followed by 75mg maintenance dose. Abciximab will be used during primary PCI, bolus plus infusion.
Other Names:
  • Plavix
  • ReoPro

Detailed Description:


In the setting of STEMI, adjunctive pharmacological therapy plays a key role in the acute management. Along with the clear benefit of mechanical reperfusion strategies, several drugs showed to be beneficial. On top of clopidogrel, heparins and IIB/IIIa glycoprotein, other drugs have been recently introduced showing encouraging results. These "new" drugs, namely prasugrel and bivalirudin, have only been compared separately.

Primary hypothesis: the combination of prasugrel/bivalirudin is superior to the combination of clopidogrel and heparin/abciximab in terms of net adverse clinical events, i.e. ischemic events plus hemorrhagic events


- patients presenting with ST-elevation myocardial infarction undergoing primary PCI

Mechanical reperfusion:

-primary percutaneous coronary intervention

Pharmacological Interventions:

- Two arms: Clopidogrel plus heparin/abciximab vs Prasugrel plus Bivalirudin

Follow up:

- 1 year


  • efficacy end points in terms of reduction of ischemic events
  • safety end points in terms of reduction of bleeding events

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • ST elevation myocardial infarction
  • No contraindication to primary PCI

Exclusion Criteria:

  • Known intolerance/allergy to one of the study drugs or their components
  • Clinical indication to treatment with oral anticoagulant, including use of warfarin or dabigatran or other oral anticoagulant agents
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01158846

Contact: Luca Testa, MD, PhD +39-3490808660

Istituto Clinico S. Ambrogio Recruiting
Milan, Italy, 20149
Contact: Luca Testa, MD, PhD    +39-3490808660   
Principal Investigator: Luca Testa, Md, PhD         
Principal Investigator: Francesco Bedogni, MD         
Sponsors and Collaborators
Istituto Clinico Sant'Ambrogio
Centro Cardiologico Monzino
Azienda Ospedaliera Niguarda Cà Granda
Istituto Clinico Humanitas
Principal Investigator: Luca Testa, MD,PhD Istituto Clinico S. Ambrogio
Study Director: Fracensco Bedogni, MD Istituto Clinico S. Ambrogio
  More Information

Responsible Party: Dr. Luca Testa, Istituto Clinico S.Ambrogio Identifier: NCT01158846     History of Changes
Other Study ID Numbers: Biva/Pra versus Abcix/clop
B/P vs A/C for STEMI ( Registry Identifier: Milan STEMI registry )
Biva/Pra versus Abcix/clop ( Registry Identifier: Biva/Pra versus Abcix/clop )
Biva/Pra versus Abcix/clop ( Registry Identifier: Milan STEMI registry )
Study First Received: June 25, 2010
Last Updated: July 7, 2010

Keywords provided by Istituto Clinico Sant'Ambrogio:
Primary PCI

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Prasugrel Hydrochloride
Antibodies, Monoclonal
Immunoglobulin Fab Fragments
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors processed this record on September 20, 2017