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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Istituto Clinico Sant'Ambrogio.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Centro Cardiologico Monzino
Azienda Ospedaliera Niguarda Cà Granda
Istituto Clinico Humanitas
Information provided by:
Istituto Clinico Sant'Ambrogio
ClinicalTrials.gov Identifier:
NCT01158846
First received: June 25, 2010
Last updated: July 7, 2010
Last verified: June 2010
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • major adverse cardiovascular events [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Combined outcome of overall death, non fatal MI, major stroke


Secondary Outcome Measures:
  • major bleedings [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    according to TIMI major bleedings definition

  • minor bleedings [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    according to TIMI minor bleedings definition

  • stent thrombosis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    according to ARC definition of probable/definite stent thrombosis

  • overall death [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • non fatal myocardial infarction [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    defined according to current guidelines

  • ischemic stroke [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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:

Background:

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

Setting:

- 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

Measurements:

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

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01158846

Contacts
Contact: Luca Testa, MD, PhD +39-3490808660 luctes@gmail.com

Locations
Italy
Istituto Clinico S. Ambrogio Recruiting
Milan, Italy, 20149
Contact: Luca Testa, MD, PhD     +39-3490808660     luctes@gmail.com    
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
Investigators
Principal Investigator: Luca Testa, MD,PhD Istituto Clinico S. Ambrogio
Study Director: Fracensco Bedogni, MD Istituto Clinico S. Ambrogio
  More Information

Publications:

Responsible Party: Dr. Luca Testa, Istituto Clinico S.Ambrogio
ClinicalTrials.gov Identifier: NCT01158846     History of Changes
Other Study ID Numbers: Biva/Pra versus Abcix/clop, B/P vs A/C for STEMI, Biva/Pra versus Abcix/clop, Biva/Pra versus Abcix/clop
Study First Received: June 25, 2010
Last Updated: July 7, 2010
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Istituto Clinico Sant'Ambrogio:
STEMI
Primary PCI
anticoagulants
antiplatelets

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Bivalirudin
Abciximab
Anticoagulants
Hirudins
Clopidogrel
Ticlopidine
 Prasugrel
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
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
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 23, 2013