Bivalirudin/Prasugrel Versus Abciximab/Clopidogrel in Patients Presenting With STEMI
Information source: Istituto Clinico Sant'Ambrogio
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: ST-Elevation Myocardial Infarction; Primary Percutaneous Coronary Intervention
Intervention: prasugrel/bivalirudin (Drug); clopidogrel/abciximab (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Istituto Clinico Sant'Ambrogio Official(s) and/or principal investigator(s): Luca Testa, MD,PhD, Principal Investigator, Affiliation: Istituto Clinico S. Ambrogio Fracensco Bedogni, MD, Study Director, Affiliation: Istituto Clinico S. Ambrogio
Overall contact: Luca Testa, MD, PhD, Phone: +39-3490808660, Email: luctes@gmail.com
Summary
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.
Clinical Details
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 design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: major adverse cardiovascular events
Secondary outcome: major bleedingsminor bleedings stent thrombosis overall death non fatal myocardial infarction ischemic stroke
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Luca Testa, MD, PhD, Phone: +39-3490808660, Email: luctes@gmail.com
Istituto Clinico S. Ambrogio, Milan 20149, Italy; Recruiting Luca Testa, MD, PhD, Phone: +39-3490808660, Email: luctes@gmail.com Luca Testa, Md, PhD, Principal Investigator Francesco Bedogni, MD, Principal Investigator
Additional Information
Related publications: Montalescot G, Wiviott SD, Braunwald E, Murphy SA, Gibson CM, McCabe CH, Antman EM; TRITON-TIMI 38 investigators. Prasugrel compared with clopidogrel in patients undergoing percutaneous coronary intervention for ST-elevation myocardial infarction (TRITON-TIMI 38): double-blind, randomised controlled trial. Lancet. 2009 Feb 28;373(9665):723-31. doi: 10.1016/S0140-6736(09)60441-4. Mehran R, Lansky AJ, Witzenbichler B, Guagliumi G, Peruga JZ, Brodie BR, Dudek D, Kornowski R, Hartmann F, Gersh BJ, Pocock SJ, Wong SC, Nikolsky E, Gambone L, Vandertie L, Parise H, Dangas GD, Stone GW; HORIZONS-AMI Trial Investigators. Bivalirudin in patients undergoing primary angioplasty for acute myocardial infarction (HORIZONS-AMI): 1-year results of a randomised controlled trial. Lancet. 2009 Oct 3;374(9696):1149-59. doi: 10.1016/S0140-6736(09)61484-7. Epub 2009 Aug 28.
Starting date: August 2010
Last updated: July 7, 2010
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