The Effect of CPC on Aborting Tilt Induced Syncope in Patients With a History of Vasovagal Syncope or Near Syncope

Summary

Syncope is defined as transient loss of consciousness associated with inability to maintain postural tone with rapid and spontaneous recovery. The purpose of this study is to assess the effects of sublingual administration of a new medication called CPC on tilt-induced syncope in patients with a history of vasovagal syncope (VVS) or near syncope. 140 participants will be randomized at the University of Wisconsin - Madison. Each participant will be in the study for 1 day.

Timeline

Start

2021-07-20

Primary completion

2023-08-25

Completion

2023-08-31

Outcome

Missed primary endpoint

registry analysis (superiority test); CPC Adminstration vs Placebo Administration; p = 0.521 NCT04972123 ↗

registry analysis (superiority test); CPC Administration vs Placebo Administration; p = 0.574 NCT04972123 ↗

Publications

• Background Bartoletti A, Alboni P, Ammirati F, Brignole M, Del Rosso A, Foglia Manzillo G, Menozzi C, Raviele A, Sutton R. 'The Italian Protocol': a simplified head-up tilt testing potentiated with oral nitroglycerin to assess patients with unexplained syncope. Europace. 2000 Oct;2(4):339-42. doi: 10.1053/eupc.2000.0125.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Caffeine	Small molecule	—	Subcutaneous
Subject	Capsaicin	Small molecule	—	Subcutaneous
Subject	Phenylephrine	Small molecule	—	Subcutaneous

Indications