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

Tracking Information
First Received Date ^ICMJE	August 19, 2005
Last Updated Date	March 22, 2007
Start Date ^ICMJE	August 2005
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: October 19, 2005)	Incidence of bleeding through the end of treatment in subjects undergoing percutaneous coronary intervention
Original Primary Outcome Measures ^ICMJE (submitted: August 19, 2005)	Incidence of bleeding through the end of treatment in subjects undergoing percutaneous coronary intervention.
Change History	Complete list of historical versions of study NCT00132912 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 19, 2005)	Incidence of bleeding throughout treatment and follow-up Incidence of death and major adverse cardiac events
Original Secondary Outcome Measures ^ICMJE (submitted: August 19, 2005)	Incidence of bleeding throughout treatment and follow-up. Incidence of death and major adverse cardiac events.

Descriptive Information
Brief Title ^ICMJE	Safety of SCH 530348 in Subjects Undergoing Non-Emergent Percutaneous Coronary Intervention (Study P03573AM1) (COMPLETED)
Official Title ^ICMJE	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of SCH 530348 in Subjects Undergoing Non-Emergent Percutaneous Coronary Intervention
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.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
Condition ^ICMJE	Arterial Obstructive Diseases Coronary Disease
Intervention ^ICMJE	Drug: SCH 530348
Study Arms / Comparison Groups
Publications *	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.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	1600
Completion Date	January 2007
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	45 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00132912
Responsible Party
Study ID Numbers ^ICMJE	P03573
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Schering-Plough
Verification Date	March 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP