BRIEF-PCI: Brief Infusion of Eptifibatide Following Percutaneous Coronary Intervention

NCT ID: NCT00111566

Last Updated: 2013-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 624 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2007-08-31

Brief Summary

This trial was designed to examine the efficacy of a brief versus a standard prolonged (18 hours) infusion of eptifibatide in preventing troponin I release following successful coronary stenting.

Detailed Description

Percutaneous coronary intervention (PCI) is a common treatment for patients with severe ischemic heart disease. In the majority of cases, the potent anti-platelet agent eptifibatide is administered (bolus followed by infusion for 18 hours). The principal reason to use eptifibatide for PCI is to prevent platelet aggregation and the associated ischemia and myocardial infarction (MI). With improved laminar flow following stenting, prolonged infusion of eptifibatide may no longer be necessary. We hypothesize that after successful stenting with good angiographic results, patients can have eptifibatide discontinued immediately without a higher risk of adverse ischemic outcome, i.e. death, MI or unplanned target vessel revascularization (TVR) by 30 days. MI is defined as creatine kinase-MB (CK-MB) concentrations elevated to more than three times the upper limit of normal or new pathologic Q wave as seen on electrocardiograms (ECG). In order to prove this hypothesis, we estimate a sample size of 2,100 patients.

Before embarking on a large-scale clinical trial, we propose a pilot study using serum troponin I elevation as a surrogate end-point. Troponin I is a sensitive biomarker of ischemic injury. The absence of troponin I release following PCI would suggest excellent short and intermediate term prognosis. For the pilot study, we seek to prove the hypothesis that following successful PCI with stenting, an abbreviated regimen of eptifibatide is not inferior to the standard infusion in preventing ischemic injury, defined as troponin I release if baseline value is normal, or as CK-MB more than 3 times upper limit of normal if baseline troponin I is elevated. For this pilot study, we estimate a sample size of 620 patients.

Conditions

Coronary Artery Disease; Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

18 Hour infusion

Group Type: ACTIVE_COMPARATOR

eptifibatide

Intervention Type: DRUG

4 hour infusion

Group Type: EXPERIMENTAL

eptifibatide

Intervention Type: DRUG

Interventions

eptifibatide

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male and non-pregnant female subjects
• 18 years of age or older
• Received aspirin, clopidogrel, heparin (unfractionated or low molecular weight [LMW]) and eptifibatide
• Had a successful PCI procedure with at least one stent deployed
• Availability of a hospital bed

Exclusion Criteria

• Use of alternative anti-thrombin therapy during PCI (e.g. bivalirudin)
• High risk patients:
• Acute ST elevation MI < 48 hours (either direct PCI or rescue PCI)
• Unprotected left main PCI
• Obvious large thrombus on angiography
• Use of rotablation, atherectomy, or thrombectomy devices
• Unsatisfactory PCI results:
• Final thrombolysis in myocardial infarction (TIMI) flow < 3
• High grade dissection (> type B, if not completely resolved at completion of PCI)
• Evident or suspected thrombus
• Distal embolization
• Suboptimal stenting (> 20% residual stenosis)
• Side branch closure (≥ 1.5 mm branch or with associated symptoms)
• Abrupt closure during procedure (if prolonged > 15 min or not resolved at completion of PCI)
• Clinical instability
• Prolonged ischemia during PCI (> 15 min)
• Increased hazard of eptifibatide infusion:
• Unsatisfactory deployment of a closure device (if used)
• Large peri-procedure hematoma making the continuation of eptifibatide hazardous
• Any condition that will increase the hazard of continuing eptifibatide
• Operator discretion
• No informed consent
• Active participation in other research studies (unless with special exemption)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: collaborator

Cardiology Research UBC

OTHER

Sponsor Role: lead

Responsible Party

Anthony Fung, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anthony Fung, MB,BS, FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

Vancouver General Hospital

Vancouver, British Columbia, Canada

Countries

Canada

References

Saw J, Densem C, Walsh S, Jokhi P, Starovoytov A, Fox R, Wong G, Buller C, Ricci D, Mancini GB, Fung A. The effects of aspirin and clopidogrel response on myonecrosis after percutaneous coronary intervention: a BRIEF-PCI (Brief Infusion of Intravenous Eptifibatide Following Successful Percutaneous Coronary Intervention) trial substudy. JACC Cardiovasc Interv. 2008 Dec;1(6):654-9. doi: 10.1016/j.jcin.2008.08.017.

Reference Type: RESULT

PMID: 19463380 (View on PubMed)

Fung AY, Saw J, Starovoytov A, Densem C, Jokhi P, Walsh SJ, Fox RS, Humphries KH, Aymong E, Ricci DR, Webb JG, Hamburger JN, Carere RG, Buller CE. Abbreviated infusion of eptifibatide after successful coronary intervention The BRIEF-PCI (Brief Infusion of Eptifibatide Following Percutaneous Coronary Intervention) randomized trial. J Am Coll Cardiol. 2009 Mar 10;53(10):837-45. doi: 10.1016/j.jacc.2008.09.060.

Reference Type: RESULT

PMID: 19264239 (View on PubMed)

Other Identifiers

C04-0359

Identifier Type: -

Identifier Source: org_study_id