Safety of SCH 530348 in Subjects Undergoing Non-Emergent Percutaneous Coronary Intervention (Study P03573AM1) (COMPLETED) - Full Text View

Purpose

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.

Condition	Intervention	Phase
Arterial Obstructive Diseases Coronary Disease	Drug: SCH 530348	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study

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

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Incidence of bleeding through the end of treatment in subjects undergoing percutaneous coronary intervention

Secondary Outcome Measures:

Incidence of bleeding throughout treatment and follow-up
Incidence of death and major adverse cardiac events

Estimated Enrollment:	1600
Study Start Date:	August 2005
Estimated Study Completion Date:	January 2007

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

Study ID Numbers:	P03573
First Received:	August 19, 2005
Last Updated:	March 22, 2007
ClinicalTrials.gov Identifier:	NCT00132912
Health Authority:	United States: Food and Drug Administration