A Phase 2 interventional study of eptifibatide and eptifibatide in ST-Elevation Myocardial Infarction, sponsored by Brigham and Women's Hospital. Terminated at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-08-27.
Sponsored by Brigham and Women's Hospital · Phase 2, Interventional, and Treatment
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.
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).
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's enrollment of 31 is below the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Clinical
AND:
ECG
Exclusion Criteria:
CLINICAL
BIOCHEMICAL
INCREASED BLEEDING RISK
MEDICATIONS
Intracoronary injection of eptifibatide
Drug: eptifibatide
Intra-coronary injection of normal saline.
Drug: normal saline
Intra-coronary injection, weight based, of eptifibatide.
Intra-coronary injection, based on weight, of eptifibatide
Intra-coronary injection, weight based, of normal saline.
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
| Milestone | Additional Bolus of Eptifibatide | Bolus of Normal Saline |
|---|---|---|
| Started | 10 | 7 |
| Completed | 10 | 7 |
| Not completed | 0 | 0 |
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Additional Bolus of Eptifibatide | — | — | — |
| Bolus of Normal Saline | — | — | — |
| Age Continuous(years) | Additional Bolus of Eptifibatide | Bolus of Normal Saline | Total |
|---|---|---|---|
| Mean | 57.9 ± 10.2 | 67 ± 9.5 | 61.6 ± 10.7 |
| Age, Customized(participants) | Additional Bolus of Eptifibatide | Bolus of Normal Saline | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 75 years | 9 | 6 | 15 |
| >=75 years | 1 | 1 | 2 |
| Sex: Female, Male(Participants) | Additional Bolus of Eptifibatide | Bolus of Normal Saline | Total |
|---|---|---|---|
| Female | 1 | 0 | 1 |
| Male | 9 | 7 | 16 |
| Region of Enrollment(participants) | Additional Bolus of Eptifibatide | Bolus of Normal Saline | Total |
|---|---|---|---|
| United States | 10 | 7 | 17 |
This study is terminated, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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Brigham and Women's Hospital