Bivalirudin/Prasugrel Versus Abciximab/Clopidogrel in Patients Presenting With STEMI
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|ClinicalTrials.gov Identifier: NCT01158846|
Recruitment Status : Unknown
Verified June 2010 by Istituto Clinico Sant'Ambrogio.
Recruitment status was: Not yet recruiting
First Posted : July 8, 2010
Last Update Posted : July 8, 2010
|Condition or disease||Intervention/treatment||Phase|
|ST-Elevation Myocardial Infarction Primary Percutaneous Coronary Intervention||Drug: prasugrel/bivalirudin Drug: clopidogrel/abciximab||Phase 4|
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
-primary percutaneous coronary intervention
- Two arms: Clopidogrel plus heparin/abciximab vs Prasugrel plus Bivalirudin
- 1 year
- efficacy end points in terms of reduction of ischemic events
- safety end points in terms of reduction of bleeding events
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||800 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||August 2010|
|Estimated Primary Completion Date :||June 2011|
|Estimated Study Completion Date :||June 2011|
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.
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)
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.
600mg loading dose of clopidogrel followed by 75mg maintenance dose. Abciximab will be used during primary PCI, bolus plus infusion.
- major adverse cardiovascular events [ Time Frame: 1 year ]Combined outcome of overall death, non fatal MI, major stroke
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01158846
|Contact: Luca Testa, MD, PhDemail@example.com|
|Istituto Clinico S. Ambrogio||Recruiting|
|Milan, Italy, 20149|
|Contact: Luca Testa, MD, PhD +39-3490808660 firstname.lastname@example.org|
|Principal Investigator: Luca Testa, Md, PhD|
|Principal Investigator: Francesco Bedogni, MD|
|Principal Investigator:||Luca Testa, MD,PhD||Istituto Clinico S. Ambrogio|
|Study Director:||Fracensco Bedogni, MD||Istituto Clinico S. Ambrogio|