ESTEEM: Eptifibatide and ST Segment Resolution Following Primary PCI

Sponsor

Medstar Health Research Institute (Other)

Overall Status

Terminated

CT.gov ID

NCT00812435

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction	Drug: eptifibitide	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Eptifibatide and ST Segment Resolution Following Primary PCI

Study Start Date :

Aug 1, 2007

Actual Primary Completion Date :

Jul 1, 2010

Actual Study Completion Date :

Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Eptifibatide PCI with administration of eptifibatide	Drug: eptifibitide Patients will be randomized to eptifibatide or no eptifibatide. If randomized to eptifibatide: 180 mcg/kg Bolus; 2 mcg/kg/min infusion immediately prior to primary PCI or at the time of PCI and for 18 - 24 hours following the PCI Second 180 mcg/kg Bolus 10 min after the first Other Names: Integrilin

Arm

Intervention/Treatment

Experimental: Eptifibatide

PCI with administration of eptifibatide

Drug: eptifibitide

Patients will be randomized to eptifibatide or no eptifibatide. If randomized to eptifibatide: 180 mcg/kg Bolus; 2 mcg/kg/min infusion immediately prior to primary PCI or at the time of PCI and for 18 - 24 hours following the PCI Second 180 mcg/kg Bolus 10 min after the first

Other Names:

Integrilin

Outcome Measures

Primary Outcome Measures

The primary endpoint will be complete ST resolution 60 minutes following primary PCI where complete ST resolution is defined as ≥70% ST resolution compared to the qualifying ECG. [In patient hopsitalization]

Secondary Outcome Measures

Complete ST resolution (defined above) at 90 and 180 minutes following primary PCI; TIMI flow at the end of the PCI; and MACE evaluation at discharge and 30 days post PCI [In-patient hospitalization and 30 days post discharge]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients >18 years old
Patients with acute myocardial infarction whose symptom onset is within 12 hours of presentation
ST-segment elevation 1 mm in 2 contiguous limb leads or 2 mm in 2 contiguous precordial leads
Patients eligible for PCI
Target lesion(s) in a native vessel
Target lesion stenosis >50% by angiography (visual estimate)
Patients who are amenable to participating in study procedures and follow-up
Patient or legal guardian has been informed and agrees to provide approved written informed consent and data privacy authorization

Exclusion Criteria:

Patients with cardiogenic shock (SBP<80 mmHg for >30 minutes or requiring pressors or IABP due to hypotension)
Patients with cardiac arrest at any point prior to intervention (within the preceeding 24 hours)
Patients on chronic warfarin (Coumadin) therapy
Patients with known bleeding diathesis or active bleeding at the time of presentation to the catheterization laboratory
Patients with known bleeding diathesis or active bleeding within prior 3 months
Patients who receive thrombolytic therapy or glycoprotein IIb/IIIa inhibitors prior to PCI (within the preceding 8 hours)
Patients with a platelet count <100,000 cells/mm3 within the preceeding 7 days
Patients with known allergies to aspirin, clopidogrel bisulfate (Plavix), heparin, bivalirudin, glycoprotein IIb/IIIa inhibitors or intravenous contrast dye that cannot be medically managed
Patients with major surgery within the past 6 months or scheduled surgery within 6 weeks
Patients with significant unprotected left main disease (stenosis >60%) or with multivessel coronary disease that will require emergent coronary artery bypass surgery
Patients with TIA or CVA within the past 30 days or any history of hemorrhagic stroke
Patients who have undergone PCI within the preceding 30 days prior to enrollment
Patients with known impaired renal function
Patient is know to be pregnant or lactating
Patients with active participation in another device or drug study
Patients with comorbidities conferring a life expectancy of less than a year
Patients with left bundle branch block