Safety of SCH 530348 in Subjects Undergoing Non-Emergent Percutaneous Coronary Intervention (Study P03573)
Phase 2
Completed
- Conditions
- Arterial Obstructive DiseasesCoronary Disease
- Registration Number
- NCT00132912
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1030
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Incidence of bleeding through the end of treatment in subjects undergoing percutaneous coronary intervention
- Secondary Outcome Measures
Name Time Method Incidence of bleeding throughout treatment and follow-up Incidence of death and major adverse cardiac events