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

Phase 4

Completed

• Conditions: Coronary Artery Disease; Myocardial Infarction
• Interventions: Drug: eptifibatide

• Registration Number: NCT00111566
• Lead Sponsor: Cardiology Research UBC

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.

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2005-05-23
• Study First Submitted QC: 2005-05-23
• Study First Posted: 2005-05-24
• Primary Completion: 2007-07
• Study Completion: 2007-08
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-27
• Last Update Posted: 2013-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 624

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
18 Hour infusion	eptifibatide	-
4 hour infusion	eptifibatide	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
30-day all-cause mortality, non-fatal myocardial infarction (MI), and unplanned target vessel revascularization (TVR)	30 days
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

Trial Locations

Locations (1)

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada