Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2026-01-01 @ 1:16 PM
Study NCT ID:
NCT00812435
Status:
TERMINATED
Last Update Posted:
2014-08-11
First Post:
2008-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Eptifibatide and ST Segment Resolution Following Primary PCI
Sponsor:
Medstar Health Research Institute
Organization:
Study Overview
Official Title:
Eptifibatide and ST Segment Resolution Following Primary PCI
Status:
TERMINATED
Status Verified Date:
2014-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESTEEM
Brief Summary:
This is a prospective, open label, randomized trial of 100 patients who present to the cardiac catheterization laboratory with an ST Elevation Myocardial Infarction for primary PCI. Patients may receive up-front unfractionated heparin or low molecular weight heparin, but not glycoprotein IIb/IIIa inhibitors or thrombolytics. Patients will be consented prior to the diagnostic catheterization and will be randomized once the patient is deemed amenable to PCI to receive eptifibatide or no eptifibatide just prior to or at the time of primary angioplasty. Patients will be randomized in a 1:1 fashion. All patients will be assessed for the primary endpoint of ST resolution at 60 minutes post PCI and followed throughout the duration of the hospitalization and up to 30 days for secondary endpoint evaluation.
Detailed Description:
The aim of this study is to evaluate the effectiveness and safety of adjunctive eptifibatide during primary PCI in patients presenting to the catheterization laboratory within 12 hours of symptom onset. The primary objective of this randomized clinical trial is to examine the safety and effectiveness of the addition of eptifibatide therapy immediately prior to or at the time of PCI in patients presenting with a STEMI for primary PCI who have not received up-front glycoprotein IIb/IIIa inhibitor therapy. The secondary objective of this clinical trial is to assess effectiveness of adjunct eptifibatide therapy with respect to the following endpoints:
* Complete ST resolution (defined above) at 90 and 180 minutes post primary PCI
* TIMI flow at the end of the PCI (as reported by the investigator at the end of the procedure)
* MACE evaluation at discharge and 30 days post PCI (MACE defined as: death, reinfarction, and need for urgent ischemia-driven target vessel revascularization)
* Stent thrombosis at discharge and 30 days
* Major Bleed (Major Bleed defined as: TIMI Major Bleeding)
* Minor Bleed (Minor Bleed defined as: TIMI Minor Bleeding)
* ST segment resolution at 60, 90 and 180 minutes based on the additional measure in the Schroder's Index:
* Partial resolution defined as 30-70% ST-segment resolution, and
* No resolution defined as \<30% ST-segment resolution.
* Complete ST resolution (defined above) at 90 and 180 minutes post primary PCI
* TIMI flow at the end of the PCI (as reported by the investigator at the end of the procedure)
* MACE evaluation at discharge and 30 days post PCI (MACE defined as: death, reinfarction, and need for urgent ischemia-driven target vessel revascularization)
* Stent thrombosis at discharge and 30 days
* Major Bleed (Major Bleed defined as: TIMI Major Bleeding)
* Minor Bleed (Minor Bleed defined as: TIMI Minor Bleeding)
* ST segment resolution at 60, 90 and 180 minutes based on the additional measure in the Schroder's Index:
* Partial resolution defined as 30-70% ST-segment resolution, and
* No resolution defined as \<30% ST-segment resolution.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: