NCT00719914

A Safety/Efficacy Study of Intracoronary Integrilin to Improve Balloon Angioplasty Outcomes for the Treatment of Heart Attacks

IntraCoronary Treatment With Integrilin To Improve ANgiographic Outcomes (IC TITAN - TIMI 47) Trial

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this research study is to try to improve the results of the standard treatment for heart attacks. Normally, heart attack patients get a fast dose and a slow dose of eptifibatide in the emergency room, shortly after arriving. This drug is usually given through a vein in the arm. However, eptifibatide can also be injected directly into the heart's blood supply just before angioplasty, a common procedure to unblock a blood vessel in the heart. This new way of giving the drug is being studying.

Detailed description

The primary objective of the IC-TITAN study is to demonstrate that an IC bolus of eptifibatide added to an upstream double-bolus and infusion regimen of eptifibatide administered intravenously and initiated early in the ER will result in significant additional clot resolution in vivo when compared with an IC injection of placebo (saline). The primary endpoint chosen to evaluate this hypothesis is the improvement in percent diameter stenosis of the culprit artery following the IC bolus administration of eptifibatide vs. IC placebo (saline) as assessed with quantitative coronary angiography (QCA).

Conditions

• ST-Elevation Myocardial Infarction

Interventions

Type	Name	Description
DRUG	eptifibatide	Intra-coronary injection, weight based, of eptifibatide.
DRUG	eptifibatide	Intra-coronary injection, based on weight, of eptifibatide
DRUG	normal saline	Intra-coronary injection, weight based, of normal saline.

Timeline

• Start date: 2007-11-01
• Primary completion: 2008-11-01
• Completion: 2009-01-01
• First posted: 2008-07-22
• Last updated: 2012-08-27
• Results posted: 2012-08-27

Locations

3 sites across 1 country: United States