Conditions: Surgical Procedures
Keywords: GSK1278863 Thoracic Aortic Aneurysm Repair
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 57
Healthy volunteers: no

Brief summary:
This study will test the hypothesis that GSK1278863 will reduce neurologic, renal, and/or cardiac ischemia in patients undergoing elective descending thoracic aorta/thoracoabdominal aortic aneurysm (DTA/TAAA) repair, a population known to be at high risk for ischemic events from their underlying pathology and the surgical complexity required to address their disease. Approximately 160 subjects will be stratified according to intervention type (surgical or endovascular repair, with the latter limited to 50% of the total study population) and randomized in a 1:1 fashion to treatment with GSK1278863 (300 milligrams \[loading dose\] followed by 100 milligrams \[mg\]/day x 4 days) or placebo starting prior to planned repair, through postoperative day 3. The duration of participation in this study is expected to be approximately 4 to 8 weeks from screening to follow-up.

Detailed description:

Arms:
arm 1: Subject will receive GSK1278863 300mg on Day-1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by GSK1278863 100mg once daily for 4 days starting from Day 0. arm 2: Subject will receive GSK1278863 matching placebo on Day-1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by GSK1278863 matching placebo once daily for 4 days starting from Day 0.

Interventions: intervention 1: GSK1278863 intervention 2: Placebo
Intervention descriptions: intervention 1: White, round biconvex, film coated tablet with unit dose strength of 100 mg for oral administration intervention 2: White, round biconvex, film coated GSK1278863 matching placebo tablet for oral administration

Protocol document: