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

This study has been completed.

First Received on August 19, 2005. Last Updated on March 22, 2007 History of Changes

Sponsor:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00132912

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease

U.S. FDA Resources

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

No publications provided by Schering-Plough

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Becker RC, Moliterno DJ, Jennings LK, Pieper KS, Pei J, Niederman A, Ziada KM, Berman G, Strony J, Joseph D, Mahaffey KW, Van de Werf F, Veltri E, Harrington RA; TRA-PCI Investigators. Safety and tolerability of SCH 530348 in patients undergoing non-urgent percutaneous coronary intervention: a randomised, double-blind, placebo-controlled phase II study. Lancet. 2009 Mar 14;373(9667):919-28.

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

Keywords provided by Schering-Plough:

Platelets
Platelet Aggregation Inhibitors
Protease-Activated Receptor 1
Hemorrhage

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Coronary Disease
Coronary Artery Disease
Vascular Diseases
Cardiovascular Diseases
Myocardial Ischemia

Heart Diseases
Arteriosclerosis
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012