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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of SCH 530348 in Subjects Undergoing Non-Emergent Percutaneous Coronary Intervention

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00132912

Enrollment

1030

Registered

2005-08-22

Start date

2005-08-30

Completion date

2007-01-28

Last updated

2017-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arterial Obstructive Diseases, Coronary Disease

Keywords

Platelets, Platelet Aggregation Inhibitors, Protease-Activated Receptor 1, Hemorrhage

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.

Interventions

DRUGSCH 530348

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Incidence of bleeding through the end of treatment in subjects undergoing percutaneous coronary intervention	—

Secondary

Measure	Time frame
Incidence of bleeding throughout treatment and follow-up	—
Incidence of death and major adverse cardiac events	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026