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EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients With Non-ST-segment Elevation Acute Coronary Syndrome (Study P03684AM2)(COMPLETED)

Primary Purpose

Myocardial Ischemia, Acute Coronary Syndrome

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Eptifibatide (Integrilin)
Placebo
Sponsored by
Organon and Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Ischemia focused on measuring myocardial infarction, acute coronary syndrome, non-ST-segment elevation, eptifibatide, Integrilin, glycoprotein IIb/IIIa inhibitor (GP IIb/IIIa), percutaneous coronary intervention (PCI), coronary artery bypass graph surgery (CABG), catheterization, angina, ischemia, cardiac ischemia, cardiovascular disease

Eligibility Criteria

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

Inclusion Criteria: Willing and able to give informed consent and comply with study procedures and follow-up through 1 year. Plan to undergo an invasive strategy after receiving study drug for 12 to 96 hours. Able to be randomized into the trial within 12 hours of having symptoms of acute coronary syndrome. Experiencing symptoms of cardiac ischemia at rest (angina or anginal equivalent) with episode(s) lasting at least 10 minutes and have at least 2 of the following: 60 years of age or more Electrocardiogram changes (ECG) Elevated troponin (protein released in the blood stream in people suffering from acute coronary syndrome) or CK-MB levels Or have all 3 of the following: Prior history of cardiovascular disease Elevated troponin or CK-MB levels 50-59 years of age Exclusion Criteria: pregnancy (known or suspected) renal dialysis within 30 days prior to randomizing in study other serious illnesses or any condition that the investigator feels would pose a significant hazard to the patient if the investigational therapy was to be initiated Stroke (hemorrhagic stroke at any time or non-hemorrhagic stroke within previous 7 days), central nervous system damage (such as neoplasm, aneurysm, intracranial surgery), bleeding disorders (including gastrointestinal bleeding), or recent major surgery or major trauma. History of certain hematologic problems following treatment with heparin or eptifibatide. Therapy with certain related drugs within a short time before randomization into the trial.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Eptifibatide

    Placebo

    Arm Description

    Eptifibatide in addition to standard of care such as standard doses of aspirin, unfractionated heparin or low-molecular-weight heparin.

    Placebo in addition to standard of care such as standard doses of aspirin, unfractionated heparin or low-molecular-weight heparin.

    Outcomes

    Primary Outcome Measures

    Incidence of the Composite of Death, Myocardial Infarction (MI), Recurrent Ischemia Requiring Urgent Revascularization (RI-UR), and Thrombotic Bail-out.

    Secondary Outcome Measures

    Incidence of the Composite of Death/MI.

    Full Information

    First Posted
    August 17, 2004
    Last Updated
    February 7, 2022
    Sponsor
    Organon and Co
    Collaborators
    Duke Clinical Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00089895
    Brief Title
    EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients With Non-ST-segment Elevation Acute Coronary Syndrome (Study P03684AM2)(COMPLETED)
    Official Title
    Early Glycoprotein IIb/IIIa Inhibition in Non-ST-segment Elevation Acute Coronary Syndrome: A Randomized, Placebo-Controlled Trial Evaluating the Clinical Benefits of Early Front-loaded Eptifibatide in the Treatment of Patients With Non-ST-segment Elevation Acute Coronary Syndrome (EARLY ACS)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    November 1, 2004 (Actual)
    Primary Completion Date
    November 1, 2008 (Actual)
    Study Completion Date
    November 1, 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Organon and Co
    Collaborators
    Duke Clinical Research Institute

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to see if early INTEGRILIN® (eptifibatide) therapy in patients with non-ST-segment elevation acute coronary syndrome (ACS) reduces the occurence of death, heart attack and urgent cardiac intervention (surgery) compared to placebo (with delayed provisional use of eptifibatide).
    Detailed Description
    This study will enroll patients who experience symptoms of acute coronary syndrome (experiencing chest pain at rest with episodes lasting at least 10 minutes) and who are planned to undergo invasive surgical procedures after being given study drug for 12 to 96 hours. There are two different treatment groups in this study; approximately half of the patients will go to each group and the likelihood of receiving study drug vs. placebo is 50/50 (like tossing a coin). Medications that are standard of care will be provided to the patients (all patients will be given aspirin and standard hospital doses of one of two other blood thinning drugs - unfractionated heparin (UFH) or low-molecular-weight heparin). Which one patients receive is at the discretion of the Investigator.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myocardial Ischemia, Acute Coronary Syndrome
    Keywords
    myocardial infarction, acute coronary syndrome, non-ST-segment elevation, eptifibatide, Integrilin, glycoprotein IIb/IIIa inhibitor (GP IIb/IIIa), percutaneous coronary intervention (PCI), coronary artery bypass graph surgery (CABG), catheterization, angina, ischemia, cardiac ischemia, cardiovascular disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    9406 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Eptifibatide
    Arm Type
    Experimental
    Arm Description
    Eptifibatide in addition to standard of care such as standard doses of aspirin, unfractionated heparin or low-molecular-weight heparin.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo in addition to standard of care such as standard doses of aspirin, unfractionated heparin or low-molecular-weight heparin.
    Intervention Type
    Drug
    Intervention Name(s)
    Eptifibatide (Integrilin)
    Other Intervention Name(s)
    Integrilin, SCH 060936, SCH 60936
    Intervention Description
    intravenous; 180 mcg/kg bolus followed by infusion of 2 mcg/kg/min for 12 to 96 hours (or longer if necessary to complete the 18- to 24-hour post-PCI infusion period, or up to 120 hours in patients who proceed to CABG [coronary artery bypass graft]); second bolus of 180 mcg/kg administered 10 minutes after first bolus.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    intravenous; delivery to match eptifibatide to maintain blind
    Primary Outcome Measure Information:
    Title
    Incidence of the Composite of Death, Myocardial Infarction (MI), Recurrent Ischemia Requiring Urgent Revascularization (RI-UR), and Thrombotic Bail-out.
    Time Frame
    96 hours after randomization
    Secondary Outcome Measure Information:
    Title
    Incidence of the Composite of Death/MI.
    Time Frame
    30 days after randomization

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Willing and able to give informed consent and comply with study procedures and follow-up through 1 year. Plan to undergo an invasive strategy after receiving study drug for 12 to 96 hours. Able to be randomized into the trial within 12 hours of having symptoms of acute coronary syndrome. Experiencing symptoms of cardiac ischemia at rest (angina or anginal equivalent) with episode(s) lasting at least 10 minutes and have at least 2 of the following: 60 years of age or more Electrocardiogram changes (ECG) Elevated troponin (protein released in the blood stream in people suffering from acute coronary syndrome) or CK-MB levels Or have all 3 of the following: Prior history of cardiovascular disease Elevated troponin or CK-MB levels 50-59 years of age Exclusion Criteria: pregnancy (known or suspected) renal dialysis within 30 days prior to randomizing in study other serious illnesses or any condition that the investigator feels would pose a significant hazard to the patient if the investigational therapy was to be initiated Stroke (hemorrhagic stroke at any time or non-hemorrhagic stroke within previous 7 days), central nervous system damage (such as neoplasm, aneurysm, intracranial surgery), bleeding disorders (including gastrointestinal bleeding), or recent major surgery or major trauma. History of certain hematologic problems following treatment with heparin or eptifibatide. Therapy with certain related drugs within a short time before randomization into the trial.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
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    EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients With Non-ST-segment Elevation Acute Coronary Syndrome (Study P03684AM2)(COMPLETED)

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