Study of GSK1278863 to Reduce Ischemic Events in Patients Undergoing Thoracic Aortic Aneurysm Repair
Status:
Completed
Trial end date:
2014-10-08
Target enrollment:
Participant gender:
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.