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

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.

Timeline

Start

2005-08-30

Primary completion

2007-01-28

Completion

2007-01-28

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. doi: 10.1016/S0140-6736(09)60230-0.

Drugs

Indications