Trial Outcomes & Findings for Daridorexant to Prevent Delirium After Heart Surgery (NCT NCT06630390)
NCT ID: NCT06630390
Last Updated: 2025-07-11
Results Overview
In this feasibility trial, the primary outcome is rate of completion for delirium assessments--not whether patients developed delirium or the scores on delirium assessments. We aimed to evaluate subjects for delirium on each of the first three days after heart surgery using the Delirium Rating Scale, Revised-98, and the 3-minute Diagnostic Interview for the Confusion Assessment Method. Delirium based on DSM-5-TR diagnostic criteria would be diagnosed using the information from these two assessments. Below we report the number of subjects evaluated on each of the postoperative days.
COMPLETED
PHASE2
11 participants
First 3 days after surgery
2025-07-11
Participant Flow
IRB approval received on October 21, 2024, and the study was concluded on February 16, 2025 (date of last study evaluation).
Participant milestones
| Measure |
Daridorexant
Oral daridorexant 50 mg (or 25 mg, if taking a moderate 3A4 inhibitor) each of the first three nights after heart surgery.
Daridorexant 50 mg: Administered consistent with labeling from the US Food and Drug Administration.
|
Placebo
Oral matching placebo each of the first three nights after heart surgery.
Placebo: Identical appearing to daridorexant
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
6
|
|
Overall Study
COMPLETED
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Daridorexant to Prevent Delirium After Heart Surgery
Baseline characteristics by cohort
| Measure |
Daridorexant
n=5 Participants
Oral daridorexant 50 mg (or 25 mg, if taking a moderate 3A4 inhibitor) each of the first three nights after heart surgery.
|
Placebo
n=6 Participants
Oral matching placebo each of the first three nights after heart surgery.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.9 years
STANDARD_DEVIATION 2.9 • n=99 Participants
|
69.6 years
STANDARD_DEVIATION 6.3 • n=107 Participants
|
68.8 years
STANDARD_DEVIATION 4.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Montreal Cognitive Assessment
|
26 units on a scale
STANDARD_DEVIATION 2.4 • n=99 Participants
|
25.8 units on a scale
STANDARD_DEVIATION 1.8 • n=107 Participants
|
25.9 units on a scale
STANDARD_DEVIATION 2.1 • n=206 Participants
|
PRIMARY outcome
Timeframe: First 3 days after surgeryPopulation: We attempted to perform delirium assessments for subjects on each of the 3 first days after surgery.
In this feasibility trial, the primary outcome is rate of completion for delirium assessments--not whether patients developed delirium or the scores on delirium assessments. We aimed to evaluate subjects for delirium on each of the first three days after heart surgery using the Delirium Rating Scale, Revised-98, and the 3-minute Diagnostic Interview for the Confusion Assessment Method. Delirium based on DSM-5-TR diagnostic criteria would be diagnosed using the information from these two assessments. Below we report the number of subjects evaluated on each of the postoperative days.
Outcome measures
| Measure |
Daridorexant
n=5 Participants
Oral daridorexant 50 mg (or 25 mg, if taking a moderate 3A4 inhibitor) each of the first three nights after heart surgery.
Daridorexant 50 mg: Administered consistent with labeling from the US Food and Drug Administration.
|
Placebo
n=6 Participants
Oral matching placebo each of the first three nights after heart surgery.
Placebo: Identical appearing to daridorexant
|
|---|---|---|
|
Delirium
Postoperative day 1
|
5 Participants
|
6 Participants
|
|
Delirium
Postoperative day 2
|
5 Participants
|
6 Participants
|
|
Delirium
Postoperative day 3
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: First 3 days after surgeryWhen evaluating subjects on each of the first 3 days after surgery, we ask subjects to rate their sleep on the preceding night using Richards-Campbell Sleep Questionnaire. This scale includes 6 items (sleep-related domains), each scored using a visual analog scale, ranging from 0 to 100. Higher scores indicate better sleep. Given that this is a feasibility study, we report the number of subjects evaluated for sleep on each of the postoperative days.
Outcome measures
| Measure |
Daridorexant
n=5 Participants
Oral daridorexant 50 mg (or 25 mg, if taking a moderate 3A4 inhibitor) each of the first three nights after heart surgery.
Daridorexant 50 mg: Administered consistent with labeling from the US Food and Drug Administration.
|
Placebo
n=6 Participants
Oral matching placebo each of the first three nights after heart surgery.
Placebo: Identical appearing to daridorexant
|
|---|---|---|
|
Sleep Disturbance
Postoperative day 1
|
5 Participants
|
6 Participants
|
|
Sleep Disturbance
Postoperative day 2
|
5 Participants
|
6 Participants
|
|
Sleep Disturbance
Postoperative day 3
|
5 Participants
|
5 Participants
|
Adverse Events
Daridorexant
Placebo
Serious adverse events
| Measure |
Daridorexant
n=5 participants at risk
Oral daridorexant 50 mg (or 25 mg, if taking a moderate 3A4 inhibitor) each of the first three nights after heart surgery.
Daridorexant 50 mg: Administered consistent with labeling from the US Food and Drug Administration.
|
Placebo
n=6 participants at risk
Oral matching placebo each of the first three nights after heart surgery.
Placebo: Identical appearing to daridorexant
|
|---|---|---|
|
Nervous system disorders
Subcortical stroke
|
0.00%
0/5 • We evaluate for potential adverse events on each of the first three postoperative days.
|
16.7%
1/6 • Number of events 1 • We evaluate for potential adverse events on each of the first three postoperative days.
|
Other adverse events
| Measure |
Daridorexant
n=5 participants at risk
Oral daridorexant 50 mg (or 25 mg, if taking a moderate 3A4 inhibitor) each of the first three nights after heart surgery.
Daridorexant 50 mg: Administered consistent with labeling from the US Food and Drug Administration.
|
Placebo
n=6 participants at risk
Oral matching placebo each of the first three nights after heart surgery.
Placebo: Identical appearing to daridorexant
|
|---|---|---|
|
Nervous system disorders
Headache
|
40.0%
2/5 • Number of events 2 • We evaluate for potential adverse events on each of the first three postoperative days.
|
33.3%
2/6 • Number of events 2 • We evaluate for potential adverse events on each of the first three postoperative days.
|
|
Nervous system disorders
Sleepiness
|
100.0%
5/5 • Number of events 5 • We evaluate for potential adverse events on each of the first three postoperative days.
|
83.3%
5/6 • Number of events 5 • We evaluate for potential adverse events on each of the first three postoperative days.
|
|
Nervous system disorders
Fatigue
|
100.0%
5/5 • Number of events 5 • We evaluate for potential adverse events on each of the first three postoperative days.
|
83.3%
5/6 • Number of events 5 • We evaluate for potential adverse events on each of the first three postoperative days.
|
|
Nervous system disorders
Dizziness
|
40.0%
2/5 • Number of events 2 • We evaluate for potential adverse events on each of the first three postoperative days.
|
50.0%
3/6 • Number of events 3 • We evaluate for potential adverse events on each of the first three postoperative days.
|
|
Gastrointestinal disorders
Nausea
|
40.0%
2/5 • Number of events 2 • We evaluate for potential adverse events on each of the first three postoperative days.
|
33.3%
2/6 • Number of events 2 • We evaluate for potential adverse events on each of the first three postoperative days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place