Safety of SCH 530348 in Subjects Undergoing Non-Emergent Percutaneous Coronary Intervention (Study P03573)
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.
|Arterial Obstructive Diseases Coronary Disease||Drug: SCH 530348||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (masked roles unspecified)
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|
- Incidence of bleeding through the end of treatment in subjects undergoing percutaneous coronary intervention
- Incidence of bleeding throughout treatment and follow-up
- Incidence of death and major adverse cardiac events
|Actual Study Start Date:||August 30, 2005|
|Study Completion Date:||January 28, 2007|
|Primary Completion Date:||January 28, 2007 (Final data collection date for primary outcome measure)|
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