Phase 2
Completed N=129
The Effect of CPC on Aborting Tilt Induced Syncope in Patients With a History of Vasovagal Syncope or Near Syncope
Syncope, Vasovagal
Source: ClinicalTrials.gov NCT04972123 ↗
Enrolled (actual)
129
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcomePrimary: Percentage of Participants Who Have Hypotensive Syncope or Near Syncope With SBP Less Than or Equal to 70 mmHG During Tilt Test — 32; 27; 33; 35 Participants — p=0.521
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Have Hypotensive Syncope or Near Syncope With SBP Less Than or Equal to 70 mmHG During Tilt Test |
32; 27; 33; 35 | 0.521 |
| PRIMARY Time to Syncope or Near-syncope After CPC or Placebo Administration |
90.1; 76.9 | 0.574 |
| SECONDARY Percentage of Patients Who Have Asystolic Pauses > 3 Seconds in the CPC and Placebo Arms |
2; 1 | 1.000 |
| SECONDARY Fatigue Scores at 1, 4, and 8 Hours Post Tilt Table Testing |
2.2; 2.0; 2.2; 2.3; 1.9; 2.6 | 0.732 |
Eligibility Criteria
Inclusion Criteria
- Established diagnosis of typical vasovagal syncope or near syncope
- Age 18-50 years
Exclusion Criteria
- Systolic BP >130 mmHg
- History of hypertension or cardiac arrhythmias
- History of cardiovascular disease or cerebral ischemic events
- Allergic reaction to any of the drug components
- Contraindication to tilt testing
- Any physical or psychological symptom, based on the clinical judgment of the investigators that would make a participant unsuitable for the study
- Any use of a medication(s) based on the clinical judgment of the investigators that would make a participant unsuitable for the study (e.g. fludrocortisone, theophylline, prazosin, doxazosin, terazosin, MAO-inhibitors, pseudoephedrine, decongestant and PDE5 inhibitors).
- Unwilling to discontinue Midodrine or beta-blocker therapy 48 hours before tilt table testing.
- Women who are pregnant (confirmed with pregnancy test on day of study) or lactating.
Data sourced from ClinicalTrials.gov (NCT04972123). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.