CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 535 enrolled
Drug / intervention
Short Tirofiban +2 moredrug
Likely dose
Short Tirofiban 25 mcg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01522417
NCT01522417Phase 2Completed

A Randomized, Multicenter, Open-Label Study to Evaluate the Efficacy of Tirofiban Using a High-Dose Bolus Plus a Shortened Infusion Duration Versus Label-Dosing Eptifibatide in Patients Undergoing Percutaneous Coronary Intervention

Medicure·interventional·Posted Jan 31, 2012·Updated May 13, 2021

In Brief

A Phase 2 clinical trial evaluating Short Tirofiban, Eptifibatide, and 1 other intervention for Myocardial Infarction and 2 related conditions. Completed, enrolled 535 participants across 13 sites.

Detailed Summary

The purpose this study is to assess whether a tirofiban regimen of a high-dose bolus plus a shortened infusion duration compared to label-dosing eptifibatide in patients undergoing percutaneous coronary intervention (PCI) is associated with a non-inferior composite rate of death, PCI-related myocardial infarction, urgent target vessel revascularization or in-hospital major bleeding within 48 hours following PCI or hospital discharge, whichever comes first.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 31, 2012
Enrollment StartApr 1, 2012
Primary CompletionDec 1, 2018
Study CompletionMar 1, 2019
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 14.4 years ago

Interventions

Short Tirofibandrug

25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion during a PCI plus 1 to 2 hours post-PCI.

Eptifibatidedrug

180 mcg/kg bolus followed by a 2.0 mcg/kg/min infusion for 12 to 18 hours, with a second 180 mcg/kg bolus 10 min after the first.

Long Tirofibandrug

25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post-PCI.