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

November 27, 2013 updated by: Anthony Fung, MD, Cardiology Research UBC

Brief Infusion of Eptifibatide Following Percutaneous Coronary Intervention

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

624

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1L8
        • Vancouver General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 18 Hour infusion
Drug: eptifibatide
Experimental: 4 hour infusion
Drug: eptifibatide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 24 Hours
24 Hours

Secondary Outcome Measures

Outcome Measure
Time Frame
30-day all-cause mortality, non-fatal myocardial infarction (MI), and unplanned target vessel revascularization (TVR)
Time Frame: 30 days
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.
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardiology Research UBC

Collaborators

University of British Columbia

Investigators

  • Principal Investigator: Anthony Fung, MB,BS, FRCPC, University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

May 23, 2005

First Submitted That Met QC Criteria

May 23, 2005

First Posted (Estimate)

May 24, 2005

Study Record Updates

Last Update Posted (Estimate)

November 28, 2013

Last Update Submitted That Met QC Criteria

November 27, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C04-0359

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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