A Safety/Efficacy Study of Intracoronary Integrilin to Improve Balloon Angioplasty Outcomes for the Treatment of Heart Attacks (IC TITAN)
This study has been terminated.
(Poor enrollment)
Sponsor:
Brigham and Women's Hospital
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
C. Michael Gibson, MS, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00719914
First received: January 7, 2008
Last updated: July 24, 2012
Last verified: July 2012
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | IntraCoronary Treatment With Integrilin To Improve ANgiographic Outcomes (IC TITAN - TIMI 47) Trial |
Resource links provided by NLM:
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 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Intracoronary injection of eptifibatide
|
Drug: eptifibatide
Intra-coronary injection, weight based, of eptifibatide.
Drug: eptifibatide
Intra-coronary injection, based on weight, of eptifibatide
|
|
Placebo Comparator: 2
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
No publications provided
| Responsible Party: | C. Michael Gibson, MS, MD, Principal Investigator, Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT00719914 History of Changes |
| Other Study ID Numbers: | T101 |
| Study First Received: | January 7, 2008 |
| Results First Received: | July 24, 2012 |
| Last Updated: | July 24, 2012 |
| 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 |
Additional relevant MeSH terms:
|
Infarction Myocardial Infarction Ischemia Pathologic Processes Necrosis Myocardial Ischemia Heart Diseases |
Cardiovascular Diseases Vascular Diseases Eptifibatide Platelet Aggregation Inhibitors Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013