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Safety of SCH 530348 in Subjects Undergoing Non-Emergent Percutaneous Coronary Intervention (Study P03573)

Primary Purpose

Arterial Obstructive Diseases, Coronary Disease

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SCH 530348
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Arterial Obstructive Diseases focused on measuring Platelets, Platelet Aggregation Inhibitors, Protease-Activated Receptor 1, Hemorrhage

Eligibility Criteria

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

Inclusion Criteria: A person who is 45 years or older and is mentally competent to provide a signed written informed consent. A person who is scheduled to undergo a percutaneous coronary intervention or a heart catheterization with the intent to undergo a percutaneous coronary intervention. If a woman is of childbearing potential (ie, before menopause), she must test negative for pregnancy and agree to use a reliable method of birth control. Exclusion Criteria: Pregnancy Recent stroke Active internal bleeding or a history of a bleeding disorder Increased risk of bleeding Severe high blood pressure Liver or kidney disease Low platelet count Condition such as alcoholism, mental illness, or drug dependence Ongoing chest pain Planned or ongoing treatment with a blood thinning medication A serious condition or illness that would interfere with participation in the study

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Incidence of bleeding through the end of treatment in subjects undergoing percutaneous coronary intervention

    Secondary Outcome Measures

    Incidence of bleeding throughout treatment and follow-up
    Incidence of death and major adverse cardiac events

    Full Information

    First Posted
    August 19, 2005
    Last Updated
    May 23, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00132912
    Brief Title
    Safety of SCH 530348 in Subjects Undergoing Non-Emergent Percutaneous Coronary Intervention (Study P03573)
    Official Title
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of SCH 530348 in Subjects Undergoing Non-Emergent Percutaneous Coronary Intervention
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    August 30, 2005 (Actual)
    Primary Completion Date
    January 28, 2007 (Actual)
    Study Completion Date
    January 28, 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    Brief Summary
    The object of the study is to determine whether different doses of SCH 530348, when added to standard medical care in persons undergoing percutaneous coronary intervention, will increase the risk of bleeding. A secondary objective is to determine whether patients treated with SCH 530348 have fewer cardiac events such as heart attack, bypass surgery, or death compared with those persons treated with the standard of care.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Arterial Obstructive Diseases, Coronary Disease
    Keywords
    Platelets, Platelet Aggregation Inhibitors, Protease-Activated Receptor 1, Hemorrhage

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    1030 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    SCH 530348
    Primary Outcome Measure Information:
    Title
    Incidence of bleeding through the end of treatment in subjects undergoing percutaneous coronary intervention
    Secondary Outcome Measure Information:
    Title
    Incidence of bleeding throughout treatment and follow-up
    Title
    Incidence of death and major adverse cardiac events

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: A person who is 45 years or older and is mentally competent to provide a signed written informed consent. A person who is scheduled to undergo a percutaneous coronary intervention or a heart catheterization with the intent to undergo a percutaneous coronary intervention. If a woman is of childbearing potential (ie, before menopause), she must test negative for pregnancy and agree to use a reliable method of birth control. Exclusion Criteria: Pregnancy Recent stroke Active internal bleeding or a history of a bleeding disorder Increased risk of bleeding Severe high blood pressure Liver or kidney disease Low platelet count Condition such as alcoholism, mental illness, or drug dependence Ongoing chest pain Planned or ongoing treatment with a blood thinning medication A serious condition or illness that would interfere with participation in the study

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19286091
    Citation
    Becker RC, Moliterno DJ, Jennings LK, Pieper KS, Pei J, Niederman A, Ziada KM, Berman G, Strony J, Joseph D, Mahaffey KW, Van de Werf F, Veltri E, Harrington RA; TRA-PCI Investigators. Safety and tolerability of SCH 530348 in patients undergoing non-urgent percutaneous coronary intervention: a randomised, double-blind, placebo-controlled phase II study. Lancet. 2009 Mar 14;373(9667):919-28. doi: 10.1016/S0140-6736(09)60230-0.
    Results Reference
    derived
    Links:
    URL
    http://www.merck.com/clinical-trials/policies-perspectives.html
    Description
    Click here to access a synopsis of the study results.
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/policies-perspectives.html

    Learn more about this trial

    Safety of SCH 530348 in Subjects Undergoing Non-Emergent Percutaneous Coronary Intervention (Study P03573)

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