Status:
RECRUITING
Daridorexant to Prevent Post-cardiotomy Delirium
Lead Sponsor:
University of Rochester
Conditions:
Postoperative Cognitive Decline
Postoperative Delirium
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief Summary
The goal of this follow-on pilot randomized clinical trial is to obtain additional preliminary data to inform a larger, adequately powered phase 2b trial of daridorexant for the prevention of postoper...
Eligibility Criteria
Inclusion
- ≥ 60 yrs;
- having surgical aortic valve surgery or coronary artery bypass graft surgery at Strong Memorial Hospital;
- can provide consent;
- able to speak, read,and write English (as the instruments, including semi-structured interviews, used in this protocol have been validated in English);
- family member or close friend for collateral.
Exclusion
- Prior cardiotomy
- Infectious endocarditis
- Emergency surgery
- Delirium at baseline (positive 3D-CAM)
- Auditory or visual impairment that prevents study procedures
- Alcohol or substance misuse (CAGE-AID score ≥ 2)
- Psychotic disorder
- Dementia-level deficits (TICS \< 27)
- Use of a prescription sleep aid at least every other night
- Use of a strong CYP3A4 inhibitor (e.g., ceritinib, clarithromycin, cobicistat, idelalisib, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, telithromycin, voriconazole)
- Daridorexant intolerance
- Severe kidney or liver impairment (Child-Pugh ≥7, Cockcroft-Gault \<30 mL/min, or on dialysis)
- Narcolepsy
- Suicidal ideation at baseline
- Any condition that, in the PI's opinion, compromises patient safety or data quality
- Additional exclusions for the NLP exploratory aim: history of traumatic brain injury or head concussions with loss of consciousness, use of corticosteroids, or history of major neurological disease or brain surgery
Key Trial Info
Start Date :
October 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT07217912
Start Date
October 14 2025
End Date
November 1 2027
Last Update
January 7 2026
Active Locations (1)
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1
University of Rochester Medical Center
Rochester, New York, United States, 14642