Trial intelligence / Profile preview

Daridorexant to Prevent Delirium After Heart Surgery

NCT07217912Phase 2

Key facts

Status: Recruiting
Start: Oct 2025
Primary completion: Nov 2027
Countries: 1
Sponsor: University of Rochester
Modality: Small Molecules

Drugs: daridorexant
Conditions: postoperative delirium (POD)

Overview

Phase 2, randomised, double-blind trial in postoperative delirium (POD) comparing daridorexant with placebo (2 arms). Primary endpoint: Delirium incidence and severity. Started Oct 2025; status: recruiting.

Design

2 arms

Study design: RandomizedDouble-blind

daridorexant
Oral daridorexant 50 mg (or 25 mg) each of the first three nights after heart surgery.
placebo
Oral matching placebo each of the first three nights after heart surgery.

Who it enrols

Patients aged 60 and older undergoing surgical aortic valve surgery or CABG, excluding those with prior cardiotomy, emergency surgery, baseline delirium, dementia, or severe kidney/liver impairment.

Endpoints

Primary

Delirium incidence and severityPostoperative Days 1-3

Secondary

Postoperative sleep qualityPostoperative Nights 1-3

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