Status:
COMPLETED
BRIEF-PCI: Brief Infusion of Eptifibatide Following Percutaneous Coronary Intervention
Lead Sponsor:
Cardiology Research UBC
Collaborating Sponsors:
University of British Columbia
Conditions:
Coronary Artery Disease
Myocardial Infarction
Eligibility:
All Genders
Phase:
PHASE4
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 (b...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
624 Patients enrolled
Trial Details
Trial ID
NCT00111566
Start Date
December 1 2004
End Date
August 1 2007
Last Update
November 28 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1L8