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

Coronary Artery Disease Clinical Trial

Official title:

Brief Infusion of Eptifibatide Following Percutaneous Coronary Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00111566
• Other study ID #: C04-0359
• Status: Completed
• Phase: Phase 4
• First received: May 23, 2005
• Last updated: November 27, 2013
• Start date: December 2004
• Est. completion date: August 2007

Study information

• Verified date: November 2013
• Source: Cardiology Research UBC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 624
• Est. completion date: August 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Drug:
• eptifibatide

Locations

Country	Name	City	State
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Cardiology Research UBC	University of British Columbia

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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 — View Citation

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 Ept — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ischemic injury is defined as troponin I release by 24 hours when the baseline troponin I is normal or by measuring creatine kinase (CK-MB) when the baseline troponin I is elevated.		24 Hours
Secondary	30-day all-cause mortality, non-fatal myocardial infarction (MI), and unplanned target vessel revascularization (TVR)		30 days
Secondary	Composite event rate of non-coronary artery bypass graft (CABG) major bleeding, all-cause mortality, non-fatal MI, and urgent TVR at 30 days post PCI.		30 days