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Eptifibatide and ST Segment Resolution Following Primary PCI (ESTEEM)

Primary Purpose

Myocardial Infarction

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
eptifibitide
Sponsored by
Medstar Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring STEMI, Patients, male or female, greater than 18 years of age, presenting with ST elevation myocardial infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Washington Hospital Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Eptifibatide

Arm Description

PCI with administration of eptifibatide

Outcomes

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.

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

Full Information

First Posted
February 17, 2008
Last Updated
August 8, 2014
Sponsor
Medstar Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00812435
Brief Title
Eptifibatide and ST Segment Resolution Following Primary PCI
Acronym
ESTEEM
Official Title
Eptifibatide and ST Segment Resolution Following Primary PCI
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Terminated
Study Start Date
August 2007 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medstar Health Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
STEMI, Patients, male or female, greater than 18 years of age, presenting with ST elevation myocardial infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eptifibatide
Arm Type
Experimental
Arm Description
PCI with administration of eptifibatide
Intervention Type
Drug
Intervention Name(s)
eptifibitide
Other Intervention Name(s)
Integrilin
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ron Waksman, MD
Organizational Affiliation
Medstar Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States

12. IPD Sharing Statement

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Eptifibatide and ST Segment Resolution Following Primary PCI

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