At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 600 enrolled
Drug / intervention
Xenon +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Cardiovascular Safety of Xenon in General Anaesthesia, in Patient With Cardiovascular Risk in Non Cardiac Surgery: A Phase III Multicenter Randomized Controlled Study
In Brief
A Phase 3 clinical trial evaluating Xenon and Sevoflurane for Elevated Cardiac Risk and Coronary Arteries Disease Risk. Completed, enrolled 600 participants across 13 sites.
Detailed Summary
The Primary Objective is to show non inferiority in cardiac safety (i.e myocardial necrosis-MN- assessed by positive cardiac Troponin I -cTnI- ultrasensitive assay) of a Xenon based general anesthesia procedure in patients with elevated cardiac risk scheduled for atherosclerotic vascular surgery (i.e patient with Coronary Arteries Disease risk) when compared to sevoflurane based general anesthesia procedure, postoperatively up to 3 days.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
CollaboratorsEurofins Biomnis, Monitoring Force Group, Inferential
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2010
First PostedMay 2010
Primary CompletionJul 2012
TodayJul 2026
First PostedMay 11, 2010
Enrollment StartMay 1, 2010
Primary CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 16.1 years ago
Interventions
Xenondrug
Sevofluranedrug