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

Sponsors and Collaborators:	Brigham and Women's Hospital Schering-Plough
Information provided by:	Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT00719914

Purpose

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.

Condition	Intervention	Phase
ST-Elevation Myocardial Infarction	Drug: eptifibatide Drug: normal saline	Phase II

MedlinePlus related topics: Angioplasty Heart Attack

Drug Information available for: Sodium chloride Eptifibatide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	IntraCoronary Treatment With Integrilin To Improve ANgiographic Outcomes (IC TITAN - TIMI 47) Trial

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:

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) [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment:	31
Study Start Date:	November 2007
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Intracoronary injection of eptifibatide	Drug: eptifibatide Intra-coronary injection, weight based, of eptifibatide. Drug: eptifibatide Intra-coronary injection, based on weight, of eptifibatide
2: Placebo Comparator Intra-coronary injection of normal saline.	Drug: normal saline Intra-coronary injection, weight based, of normal saline.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00719914

Locations

United States, Florida
Cardiology Research Associates
Ormond Beach, Florida, United States, 32174
United States, Michigan
Crittenton Hospital Medical Center
Rochester, Michigan, United States, 48307
United States, Ohio
Mid Ohio Heart Clinic
Mansfield, Ohio, United States, 44906

Sponsors and Collaborators

Brigham and Women's Hospital

Schering-Plough

Investigators

Study Chair:	Eugene Braunwald, M.D.	TIMI Study Group
Principal Investigator:	C. Michael Gibson, M.D.	TIMI Study Group

More Information

Responsible Party:	Brigham and Women's Hospital, Inc. ( C.Michael Gibson, M.S., M.D. )
Study ID Numbers:	T101
Study First Received:	January 7, 2008
Last Updated:	July 18, 2008
ClinicalTrials.gov Identifier:	NCT00719914
Health Authority:	United States: Food and Drug Administration

Keywords provided by Brigham and Women's Hospital:

eptifibatide
Integrilin
ST-Elevation Myocardial Infarction
Acute Myocardial Infarction

Study placed in the following topic categories:

Necrosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Ischemia
Eptifibatide
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Pathologic Processes
Therapeutic Uses
Hematologic Agents

Platelet Aggregation Inhibitors
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009