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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

June 25, 2010
July 7, 2010
August 2010
June 2011   (final data collection date for primary outcome measure)
major adverse cardiovascular events [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Combined outcome of overall death, non fatal MI, major stroke
Same as current
Complete list of historical versions of study NCT01158846 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Bivalirudin/Prasugrel Versus Abciximab/Clopidogrel in Patients Presenting With STEMI
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

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.

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
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • ST-Elevation Myocardial Infarction
  • Primary Percutaneous Coronary Intervention
  • 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
  • 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
  • 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.
    Intervention: Drug: prasugrel/bivalirudin
  • 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.
    Intervention: Drug: clopidogrel/abciximab

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
800
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Luca Testa, MD, PhD +39-3490808660 luctes@gmail.com
Italy
 
NCT01158846
Biva/Pra versus Abcix/clop, B/P vs A/C for STEMI, Biva/Pra versus Abcix/clop, Biva/Pra versus Abcix/clop
No
Dr. Luca Testa, Istituto Clinico S.Ambrogio
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
Istituto Clinico Sant'Ambrogio
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP