Safety of SCH 530348 in Subjects Undergoing Non-Emergent Percutaneous Coronary Intervention (Study P03573)
May 23, 2017 updated by: Merck Sharp & Dohme LLC
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of SCH 530348 in Subjects Undergoing Non-Emergent Percutaneous Coronary Intervention
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1030
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
Incidence of bleeding through the end of treatment in subjects undergoing percutaneous coronary intervention
|
Secondary Outcome Measures
Outcome Measure |
|---|
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Incidence of bleeding throughout treatment and follow-up
|
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Incidence of death and major adverse cardiac events
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 30, 2005
Primary Completion (Actual)
January 28, 2007
Study Completion (Actual)
January 28, 2007
Study Registration Dates
First Submitted
August 19, 2005
First Submitted That Met QC Criteria
August 19, 2005
First Posted (Estimate)
August 22, 2005
Study Record Updates
Last Update Posted (Actual)
May 25, 2017
Last Update Submitted That Met QC Criteria
May 23, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P03573
Plan for Individual participant data (IPD)
Study Data/Documents
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.