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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 2

Conditions

Arterial Obstructive Diseases

Coronary Disease

Treatments

Drug: SCH 530348

Study type

Interventional

Funder types

Industry

Identifiers

NCT00132912

P03573

Details and patient eligibility

About

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.

Enrollment

1,030 patients

Sex

All

Ages

45+ years old

Volunteers

No 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