Eptifibatide and ST Segment Resolution Following Primary PCI (ESTEEM)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Medstar Research Institute
ClinicalTrials.gov Identifier:
NCT00812435
First received: February 17, 2008
Last updated: August 8, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Myocardial Infarction
Drug: eptifibitide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Eptifibatide and ST Segment Resolution Following Primary PCI

Resource links provided by NLM:


Further study details as provided by Medstar Research Institute:

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. [ Time Frame: In patient hopsitalization ] [ Designated as safety issue: Yes ]

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 [ Time Frame: In-patient hospitalization and 30 days post discharge ] [ Designated as safety issue: Yes ]

Enrollment: 22
Study Start Date: August 2007
Study Completion Date: March 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Integrilin

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00812435

Locations
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Medstar Research Institute
Investigators
Principal Investigator: Ron Waksman, MD Medstar Research Institute
  More Information

No publications provided

Responsible Party: Medstar Research Institute
ClinicalTrials.gov Identifier: NCT00812435     History of Changes
Other Study ID Numbers: ESTEEM
Study First Received: February 17, 2008
Last Updated: August 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Medstar Research Institute:
STEMI
Patients
male or female
greater than 18 years of age
presenting with ST elevation myocardial infarction

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases
Eptifibatide
Hematologic Agents
Pharmacologic Actions
Platelet Aggregation Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014