Safety of SCH 530348 in Subjects Undergoing Non-Emergent Percutaneous Coronary Intervention (Study P03573)
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of SCH 530348 in Subjects Undergoing Non-Emergent Percutaneous Coronary Intervention
1 other identifier
interventional
1,030
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2005
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2005
CompletedFirst Posted
Study publicly available on registry
August 22, 2005
CompletedStudy Start
First participant enrolled
August 30, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 28, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 28, 2007
CompletedMay 25, 2017
May 1, 2017
1.4 years
August 19, 2005
May 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of bleeding through the end of treatment in subjects undergoing percutaneous coronary intervention
Secondary Outcomes (2)
Incidence of bleeding throughout treatment and follow-up
Incidence of death and major adverse cardiac events
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 19286091DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2005
First Posted
August 22, 2005
Study Start
August 30, 2005
Primary Completion
January 28, 2007
Study Completion
January 28, 2007
Last Updated
May 25, 2017
Record last verified: 2017-05