Safety of SCH 530348 in Subjects Undergoing Non-Emergent... | NCT00132912

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

NCT00132912

Sponsor

Merck Sharp & Dohme LLC

Status

Completed

Last Update Posted

May 25, 2017Actual

Enrollment

1,030Actual

Phase

Phase 2

Conditions

Arterial Obstructive Diseases
Coronary Disease

Interventions

SCH 530348

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 30, 2005Actual

Primary Completion Date

Jan 28, 2007Actual

Completion Date

Jan 28, 2007Actual

First Submitted Date

Aug 19, 2005

First Submission Date that Met QC Criteria

Aug 19, 2005

First Posted Date

Aug 22, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 23, 2017

Last Update Posted Date

May 25, 2017Actual

Description Module

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,030Actual

Name	Type	Description	Arm Group Labels	Other Names
SCH 530348	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of bleeding through the end of treatment in subjects undergoing percutaneous coronary intervention

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19286091	Derived	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. doi: 10.1016/S0140-6736(09)60230-0.

ID	Term
D001157	Arterial Occlusive Diseases
D003327	Coronary Disease
D006470	Hemorrhage

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D017202	Myocardial Ischemia
D006331	Heart Diseases