Not Yet Recruiting PHASE2 INTERVENTIONAL 2-arm NCT06648681

Lemborexant to Prevent Post-operative Delirium in Cardiac Surgery Patients (PROTEX)

A Randomized Trial of Lemborexant for the Prevention of Delirium After Cardiac Surgery (PROTEX): A Pilot Study

Sponsor: Eisai Inc.

Conditions Cardiac Surgery Cardiac Surgery Subjects Delirium - Postoperative Feasibility Studies In-hospital Mortality Orexin Antagonist Sleep

Interventions Control (placebo) group Lemborexant 5 mg

Updated 3 times since 2024 Last updated: Apr 18, 2025 Started: May 1, 2025 Primary completion: Apr 30, 2027 Completion: Apr 30, 2027

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates Cardiac Surgery and Cardiac Surgery Subjects and is currently actively recruiting participants. Eisai Inc. leads this study, which shows 3 recorded versions since 2025 — indicating limited longitudinal coverage. Heart and vascular conditions benefit from the kind of long-term tracking this trial provides.

Status Flow

Change History

3 versions recorded

May 2025 — Present [monthly]

Not Yet Recruiting PHASE2
Dec 2024 — May 2025 [monthly]

Not Yet Recruiting PHASE2
Nov 2024 — Dec 2024 [monthly]

Not Yet Recruiting PHASE2

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Eisai Inc.
Providence Health Care, British Columbia
St. Paul's Hospital, Vancouver (Providence Health Care)
University of British Columbia

Data source: University of British Columbia

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Vancouver, Canada