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

NCT01158846 | Unknown Phase 4

• 2 other identifiers: Biva/Pra versus Abcix/clopB/P vs A/C for STEMI
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

ST-Elevation Myocardial Infarction; Primary Percutaneous Coronary Intervention

Keywords

STEMI; Primary PCI; anticoagulants; antiplatelets

Outcome Measures

Primary Outcomes (1)

• major adverse cardiovascular events

  Combined outcome of overall death, non fatal MI, major stroke

  1 year

Secondary Outcomes (6)

• major bleedings

  1 year

• minor bleedings

  1 year

• stent thrombosis

  1 year

• overall death

  1 year

• non fatal myocardial infarction

  1 year

Study Arms (2)

prasugrel/bivalirudin

ACTIVE COMPARATOR

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.

Drug: prasugrel/bivalirudin

clopidogrel/abciximab

ACTIVE COMPARATOR

600mg loading dose of clopidogrel will be followed by 75mg maintenance dose. During primary PCI abciximab (bolus plus infusion) will be used as anticoagulant.

Drug: clopidogrel/abciximab

Interventions

prasugrel/bivalirudin 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)

Also known as: Efient, Angiox

prasugrel/bivalirudin

clopidogrel/abciximab DRUG

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

Also known as: Plavix, ReoPro

clopidogrel/abciximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ST elevation myocardial infarction
• No contraindication to primary PCI

You may not qualify if:

• 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

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead
• Centro Cardiologico Monzino: collaborator
• Azienda Ospedaliera Niguarda Cà Granda: collaborator
• Istituto Clinico Humanitas: collaborator

Study Sites (1)

Istituto Clinico S. Ambrogio

Milan, 20149, Italy

Location

Related Publications (2)

• 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.

  PMID: 19249633 BACKGROUND

• 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.

  PMID: 19717185 BACKGROUND

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Prasugrel Hydrochloride; bivalirudin; Clopidogrel; Abciximab

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ticlopidine; Thienopyridines; Pyridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Luca Testa, MD,PhD

  Istituto Clinico S. Ambrogio

  PRINCIPAL INVESTIGATOR

• Fracensco Bedogni, MD

  Istituto Clinico S. Ambrogio

  STUDY DIRECTOR

Central Study Contacts

Luca Testa, MD, PhD

CONTACT

+39-3490808660; luctes@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 25, 2010
• First Posted: July 8, 2010
• Study Start: August 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: July 8, 2010

Record last verified: 2010-06

Locations

IT (1)