Conditions: Acute Coronary Syndrome
Keywords: NSTEMI, acute coronary syndrome, p38 MAPK inhibitor, GW856553, percutaneous coronary intervention
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 526
Healthy volunteers: no

Brief summary:
This is a randomized, double-blind, placebo-controlled, parallel group, multi-center study to evaluate initial safety and efficacy of GW856553 in subjects with NSTEMI. Up to approximately 525 subjects will be randomized to meet the MRI recruitment target (90 subjects in substudy.) All subjects will continue to receive the local standard of care for the duration of the study.

Detailed description:

Arms:
arm 1: 7.5 mg GW856553 starting dose, followed 12 hours later by 7.5mg twice daily for 12 weeks arm 2: 15 mg GW856553 starting dose, followed 12 hours later by 7.5mg twice daily for 12 weeks arm 3: Placebo twice daily for 12 weeks

Interventions: intervention 1: GW856553 intervention 2: GW856553 intervention 3: Placebo
Intervention descriptions: intervention 1: 7.5 mg GW856553 starting dose, followed 12 hours later by 7.5mg BID intervention 2: 15 mg GW856553 starting dose, followed 12 hours later by 7.5mg BID intervention 3: Placebo

Protocol document: