Back to resultsSafety 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
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
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
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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