Overview
BRIEF-PCI: Brief Infusion of Eptifibatide Following Percutaneous Coronary Intervention
Status:
Completed
Completed
Trial end date:
2007-08-01
2007-08-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Cardiology Research UBCCollaborator:
University of British ColumbiaTreatments:
Eptifibatide
Polystyrene sulfonic acid
Criteria
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)