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

Coronary Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00132912
• Other study ID #: P03573
• Status: Completed
• Phase: Phase 2
• First received: August 19, 2005
• Last updated: May 23, 2017
• Start date: August 30, 2005
• Est. completion date: January 28, 2007

Study information

• Verified date: May 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1030
• Est. completion date: January 28, 2007
• Est. primary completion date: January 28, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arterial Obstructive Diseases
• Arterial Occlusive Diseases
• Coronary Artery Disease
• Coronary Disease

Intervention

Drug:
• SCH 530348

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of bleeding through the end of treatment in subjects undergoing percutaneous coronary intervention
Secondary	Incidence of bleeding throughout treatment and follow-up
Secondary	Incidence of death and major adverse cardiac events

External Links

•   Click here to access a synopsis of the study results.