Overview

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

Status:
Completed
Trial end date:
2007-08-01
Target enrollment:
0
Participant gender:
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 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Cardiology Research UBC
Collaborator:
University of British Columbia
Treatments:
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)