Study of Ondansetron in the Prevention of Sleep Syncope: The Nineth Prevention of Syncope Trial (POST9)

Launched by UNIVERSITY OF CALGARY · Dec 12, 2022

Keywords

ClinConnect Summary

Trial interventions: Randomization will be to ondansetron 8 mg sublingual tablets or matching placebo tablets kept at the bedside, to be used upon awakening with premonitory nausea. This is a commonly used dose for rapid treatment of nausea.

Randomization: Patients will be randomized into two treatment groups will be carried out centrally with a randomization scheme using a computerized algorithm. Medication containers will be filled and labelled with the randomization code number centrally. The investigators will complete a screening log of eligible but nonrandomized patients that will co...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Syncope according to the American College of Cardiology Guidelines 2017
• • 2. ≥1 Sleep Syncope in the year preceding enrolment
• • 3. ≥-2 points on the Calgary Syncope Symptom Score for Structurally Normal Hearts
• • 4. Age ≥ 18 years with informed consent.
• Exclusion Criteria:
• • 1. An inability to give informed consent
• • 2. pregnancy,
• • 3. unwilling or unable to use adequate birth control while on study drug
• • 4. QT interval exceeding 500 ms in the absence of correctable factors.