Clinical trial NCT00719914: A Safety/Efficacy Study of Intracoronary Integrilin to Improve Balloon Angioplasty Outcomes for the Treatment of Heart Attacks
Official title: IntraCoronary Treatment With Integrilin To Improve ANgiographic Outcomes (IC TITAN - TIMI 47) Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: ST-Elevation Myocardial Infarction
Keywords: eptifibatide
Integrilin
ST-Elevation Myocardial Infarction
Acute Myocardial Infarction
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Schering-Plough
First posted: 2008-07-22
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ormond Beach
country: United States
facility: Cardiology Research Associates
state: Florida
city: Rochester
country: United States
facility: Crittenton Hospital Medical Center
state: Michigan
city: Mansfield
country: United States
facility: Mid Ohio Heart Clinic
state: Ohio
Study officials:
affiliation: The TIMI Study Group
name: Eugene Braunwald, M.D.
role: STUDY_CHAIR
affiliation: The TIMI Study Group
name: C. Michael Gibson, M.D.
role: PRINCIPAL_INVESTIGATOR
References: