ST-Elevation Myocardial Infarction
Conditions
Keywords
eptifibatide, Integrilin, ST-Elevation Myocardial Infarction, Acute Myocardial Infarction
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).
Interventions
DRUGeptifibatide
Intra-coronary injection, weight based, of eptifibatide.
DRUGnormal saline
Intra-coronary injection, weight based, of normal saline.
Sponsors
Schering-Plough
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Additional Bolus of Eptifibatide Intracoronary injection of eptifibatide | 10 |
| Bolus of Normal Saline Intra-coronary injection of normal saline. | 7 |
| Total | 17 |
Baseline characteristics
| Characteristic | Additional Bolus of Eptifibatide | Bolus of Normal Saline | Total |
|---|---|---|---|
| Age Continuous | 57.9 years STANDARD_DEVIATION 10.2 | 67 years STANDARD_DEVIATION 9.5 | 61.6 years STANDARD_DEVIATION 10.7 |
| Age, Customized <=18 years | 0 participants | 0 participants | 0 participants |
| Age, Customized >=75 years | 1 participants | 1 participants | 2 participants |
| Age, Customized Between 18 and 75 years | 9 participants | 6 participants | 15 participants |
| Region of Enrollment United States | 10 participants | 7 participants | 17 participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 9 Participants | 7 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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)
Time frame: 30 days
Population: study terminated due to low enrollment