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

NCT ID: NCT01158846

Last Updated: 2010-07-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2011-06-30

Brief 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.

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

Conditions

ST-Elevation Myocardial Infarction; Primary Percutaneous Coronary Intervention

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

prasugrel/bivalirudin

Intervention Type: DRUG

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 will be followed by 75mg maintenance dose. During primary PCI abciximab (bolus plus infusion) will be used as anticoagulant.

Group Type: ACTIVE_COMPARATOR

clopidogrel/abciximab

Intervention Type: DRUG

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

Interventions

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)

Intervention Type: DRUG

clopidogrel/abciximab

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

Intervention Type: DRUG

Other Intervention Names

Efient; Angiox; Plavix; ReoPro

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centro Cardiologico Monzino

OTHER

Sponsor Role: collaborator

Azienda Ospedaliera Niguarda Cà Granda

OTHER

Sponsor Role: collaborator

Istituto Clinico Humanitas

OTHER

Sponsor Role: collaborator

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

OTHER

Sponsor Role: lead

Responsible Party

Istituto Clinico S.Ambrogio

Principal Investigators

Luca Testa, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Istituto Clinico S. Ambrogio

Fracensco Bedogni, MD

Role: STUDY_DIRECTOR

Istituto Clinico S. Ambrogio

Locations

Istituto Clinico S. Ambrogio

Milan, , Italy

Countries

Italy

Central Contacts

Luca Testa, MD, PhD

Role: CONTACT

luctes@gmail.com

+39-3490808660

Facility Contacts

Luca Testa, MD, PhD

Role: primary

luctes@gmail.com

+39-3490808660

References

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.

Reference Type: BACKGROUND

PMID: 19249633 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19717185 (View on PubMed)

Other Identifiers

B/P vs A/C for STEMI

Identifier Type: REGISTRY

Identifier Source: secondary_id

Biva/Pra versus Abcix/clop

Identifier Type: REGISTRY

Identifier Source: secondary_id

Biva/Pra versus Abcix/clop

Identifier Type: REGISTRY

Identifier Source: secondary_id

Biva/Pra versus Abcix/clop

Identifier Type: -

Identifier Source: org_study_id