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

ST-Elevation Myocardial Infarction Clinical Trial

— IC TITAN  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00719914
• Other study ID #: T101
• Status: Terminated
• Phase: Phase 2
• First received: January 7, 2008
• Last updated: July 24, 2012
• Start date: November 2007
• Est. completion date: January 2009

Study information

• Verified date: July 2012
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: January 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Clinical

• Patients (men or women) at least 18 years of age and

• Presenting with ischemic chest discomfort >20 minutes and <6 hours of duration suggestive of acute myocardial infarction

AND:

ECG

• ST elevation >1mm (>0.1mV) in two contiguous limb leads OR >2mm (>0.2mV) in two contiguous precordial leads

Exclusion Criteria:

CLINICAL

• Maximal systolic blood pressure <80 mmHg AFTER initial fluid and/or pressor resuscitation

• Uncontrolled hypertension (SBP>180 OR DBP >110) at time of enrollment

• Ventricular fibrillation or ventricular tachycardia requiring DC cardioversion

• Sinus bradycardia (HR <50/min), third degree or advanced second degree heart block.

• Known pregnancy

• New or suspected new left bundle branch block

BIOCHEMICAL

• Known thrombocytopenia (platelet count <100,000)

• Known severe renal insufficiency (creatinine >4.0 mg/dL)

INCREASED BLEEDING RISK

• Active or recent (<1 year) bleeding or gastrointestinal hemorrhage

• Major surgery <1 month

• Known coagulopathy, platelet disorder or history of thrombocytopenia: If a patient is known to be on chronic warfarin therapy, the International Normalized Ratio (INR) must be known to be <1.6 in order for the patient to be included

• Known neoplasm

• Any history of hemorrhagic cerebrovascular disorder or active intracranial pathology

MEDICATIONS

• Administration of a fibrinolytic agent within 7 days

• Known allergy or contraindication to eptifibatide OR aspirin OR heparin

• Treatment with another GP IIb/IIIa inhibitor within 7 days

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST-Elevation Myocardial Infarction

Intervention

Drug:
• eptifibatide
Intra-coronary injection, weight based, of eptifibatide.
• eptifibatide
Intra-coronary injection, based on weight, of eptifibatide
• normal saline
Intra-coronary injection, weight based, of normal saline.

Locations

Country	Name	City	State
United States	Mid Ohio Heart Clinic	Mansfield	Ohio
United States	Cardiology Research Associates	Ormond Beach	Florida
United States	Crittenton Hospital Medical Center	Rochester	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Schering-Plough

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		30 days	No