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

ST-Elevation Myocardial Infarction Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01158846
• Other study ID #: Biva/Pra versus Abcix/clop
• Secondary ID: B/P vs A/C for S
• Status: Not yet recruiting
• Phase: Phase 4
• First received: June 25, 2010
• Last updated: July 7, 2010
• Start date: August 2010
• Est. completion date: June 2011

Study information

• Verified date: June 2010
• Source: Istituto Clinico Sant'Ambrogio
• Contact: Luca Testa, MD, PhD
• Phone: +39-3490808660
• Email: luctes[@]gmail.com
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 800
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Primary Percutaneous Coronary Intervention
• ST-Elevation Myocardial Infarction

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)
• clopidogrel/abciximab
600mg loading dose of clopidogrel followed by 75mg maintenance dose. Abciximab will be used during primary PCI, bolus plus infusion.

Locations

Country	Name	City	State
Italy	Istituto Clinico S. Ambrogio	Milan

Sponsors (4)

Lead Sponsor	Collaborator
Istituto Clinico Sant'Ambrogio	Azienda Ospedaliera Niguarda Cà Granda, Centro Cardiologico Monzino, Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	major adverse cardiovascular events	Combined outcome of overall death, non fatal MI, major stroke	1 year	No
Secondary	major bleedings	according to TIMI major bleedings definition	1 year	Yes
Secondary	minor bleedings	according to TIMI minor bleedings definition	1 year	Yes
Secondary	stent thrombosis	according to ARC definition of probable/definite stent thrombosis	1 year	No
Secondary	overall death		1 year	No
Secondary	non fatal myocardial infarction	defined according to current guidelines	1 year	No
Secondary	ischemic stroke		1 year	No