drugset / Trial / NCT01454440

The INtegrilin Plus STenting to Avoid Myocardial Necrosis Trial (INSTANT)

NCT01454440 ↗

Phase 4 Terminated 91 enrolled University of Turin, Italy
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

EvaluationDrugModalityDoseRoute
Subject Eptifibatide Other / unclassified 2 ug/kg Intravenous