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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 bleedings

minor 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

Page last updated: August 23, 2015

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