drugset / Trial / NCT01454440
The INtegrilin Plus STenting to Avoid Myocardial Necrosis Trial (INSTANT)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Patients with stable coronary artery disease, undergoing PCI by means of implantation of \>33 mm of DES, will be randomized single-blinded to eptifibatide plus unfractioned heparin according to the ESPRIT protocol vs placebo plus unfractioned heparin.
Timeline
- Start
- 2007-10
- Primary completion
- 2009-10
- Completion
- 2009-10
Outcome
Missed primary endpoint
Stopped: “The study was stopped prematurely due to slow enrolment without code breaking.”
paper Analysis for the primary end point showed a trend toward lower rates of abnormal post-PCI creatine kinase-MB mass values PMID 22607870 ↗
paper the heparin-plus-eptifibatide group (18 [41%]) versus the heparin-alone group (26 [55%], relative risk 0.74 [95% CI 0.48-1.15], P = .169). PMID 22607870 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Eptifibatide | Other / unclassified | 2 ug/kg | Intravenous |