NCT00111566

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
624

participants targeted

Target at P75+ for phase_4 coronary-artery-disease

Timeline
Completed

Started Dec 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 24, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

November 28, 2013

Status Verified

November 1, 2013

Enrollment Period

2.6 years

First QC Date

May 23, 2005

Last Update Submit

November 27, 2013

Conditions

Coronary Artery DiseaseMyocardial Infarction

Keywords

Percutaneous Coronary Intervention (PCI)Glycoprotein IIb/IIIa blockadeIschemic complications following PCI

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Study Arms (2)

18 Hour infusion

ACTIVE COMPARATOR
Drug: eptifibatide

4 hour infusion

EXPERIMENTAL
Drug: eptifibatide

Interventions

eptifibatideDRUG
18 Hour infusion4 hour infusion

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male and non-pregnant female subjects
  • 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

You may not qualify if:

  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1L8, Canada

Location

Related Publications (2)

  • 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.

    PMID: 19463380RESULT

  • 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.

    PMID: 19264239RESULT

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial Infarction

Interventions

Eptifibatide

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Peptides, CyclicPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Anthony Fung, MB,BS, FRCPC

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 23, 2005

First Posted

May 24, 2005

Study Start

December 1, 2004

Primary Completion

July 1, 2007

Study Completion

August 1, 2007

Last Updated

November 28, 2013

Record last verified: 2013-11

Locations

CA(1)