Eptifibatide and ST Segment Resolution Following Primary PCI

NCT00812435 | Terminated Phase 3 DMC

• 1 other identifier: ESTEEM
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction

Keywords

STEMI; Patients; male or female; greater than 18 years of age; presenting with ST elevation myocardial infarction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Eptifibatide

EXPERIMENTAL

PCI with administration of eptifibatide

Drug: eptifibitide

Interventions

eptifibitide DRUG

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

Also known as: Integrilin

Eptifibatide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Study Sites (1)

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Myocardial Infarction; ST Elevation Myocardial Infarction

Interventions

Eptifibatide

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Ron Waksman, MD

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2008
• First Posted: December 22, 2008
• Study Start: August 1, 2007
• Primary Completion: July 1, 2010
• Study Completion: March 1, 2011
• Last Updated: August 11, 2014

Record last verified: 2014-08

Locations

US (1)