Trial · NCT04972123
The Effect of CPC on Aborting Tilt Induced Syncope in Patients With a History of Vasovagal Syncope or Near Syncope
NCT04972123, Phase 2, Completed, University of Wisconsin, Madison; results first posted 2024-06-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Effect of CPC on Aborting Tilt Induced Syncope in Patients With a History of Vasovagal Syncope or Near Syncope. Trials, record NCT04972123. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04972123
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Effect of CPC on Aborting Tilt Induced Syncope in Patients With a History of Vasovagal Syncope or Near Syncope
- NCT number
- NCT04972123
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 143 participants, actual
- Lead sponsor
- University of Wisconsin, Madison
- Conditions
- Syncope, Vasovagal
- Interventions
- CPC - Capsaicin, Phenylephrine, Caffeine, Tilt Table Test, Placebo
- First posted
- 2021-07-22
- Last updated
- 2024-07-17
- Results first posted
- 2024-06-24
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Have Hypotensive Syncope or Near Syncope With SBP Less Than or Equal to 70 mmHG During Tilt Test | During tilt table testing (up to approximately 35 minutes) | Hypotensive syncope is defined as transient loss of consciousness associated with SBP less than or equal to 90 mmHg. Near syncope is defined as sensation of "near fainting" while still being responsive to verbal commands. Near syncope will be used as a primary endpoint only when it is associated with a SBP less than or equal to 70 mmHg. |
| Primary | Time to Syncope or Near-syncope After CPC or Placebo Administration | During tilt table testing (up to approximately 35 minutes) | Time in seconds from CPC or Placebo administration to syncope or near syncope in patients who had an event |
| Secondary | Percentage of Patients Who Have Asystolic Pauses > 3 Seconds in the CPC and Placebo Arms | During tilt table testing (up to approximately 35 minutes) | Percentage of Participants with an event who had asystolic pauses \> 3 seconds during syncope or near syncope |
| Secondary | Fatigue Scores at 1, 4, and 8 Hours Post Tilt Table Testing | Up to 8 hours after tilt table testing (up to approximately 8 hours and 35 minutes) | Fatigue Scores at 1, 4 and 8 hours post tilt table testing in participants who had an event. Using standard continuous fatigue scale of 1 to 5, with 1 = no fatigue and 5 = max fatigue. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Have Hypotensive Syncope or Near Syncope With SBP Less Than or Equal to 70 mmHG During Tilt Test | During tilt table testing (up to approximately 35 minutes) | Intention to treat based on randomized treatment assignment | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Time to Syncope or Near-syncope After CPC or Placebo Administration | During tilt table testing (up to approximately 35 minutes) | Secondary endpoints analyses were limited to participants who had syncope or near syncope | seconds | MEDIAN |
| SECONDARY | Percentage of Patients Who Have Asystolic Pauses > 3 Seconds in the CPC and Placebo Arms | During tilt table testing (up to approximately 35 minutes) | Secondary endpoints analyses were limited to participants who had syncope or near syncope | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Fatigue Scores at 1, 4, and 8 Hours Post Tilt Table Testing | Up to 8 hours after tilt table testing (up to approximately 8 hours and 35 minutes) | Secondary endpoints analyses were limited to participants who had syncope or near syncope | Score on a scale | MEDIAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Have Hypotensive Syncope or Near Syncope With SBP Less Than or Equal to 70 mmHG During Tilt Test | CPC Adminstration | Number of participants with syncope or near syncope event | 32 | Participants | |
| Percentage of Participants Who Have Hypotensive Syncope or Near Syncope With SBP Less Than or Equal to 70 mmHG During Tilt Test | Placebo Administration | Number of participants with syncope or near syncope event | 27 | Participants | |
| Percentage of Participants Who Have Hypotensive Syncope or Near Syncope With SBP Less Than or Equal to 70 mmHG During Tilt Test | CPC Adminstration | Number of participants without syncope or near syncope event | 33 | Participants | |
| Percentage of Participants Who Have Hypotensive Syncope or Near Syncope With SBP Less Than or Equal to 70 mmHG During Tilt Test | Placebo Administration | Number of participants without syncope or near syncope event | 35 | Participants | |
| Time to Syncope or Near-syncope After CPC or Placebo Administration | CPC Administration | 90.1 | Standard Deviation 95.0 | seconds | |
| Time to Syncope or Near-syncope After CPC or Placebo Administration | Placebo Administration | 76.9 | Standard Deviation 95.0 | seconds | |
| Percentage of Patients Who Have Asystolic Pauses > 3 Seconds in the CPC and Placebo Arms | CPC Administration | 2 | Participants | ||
| Percentage of Patients Who Have Asystolic Pauses > 3 Seconds in the CPC and Placebo Arms | Placebo Administration | 1 | Participants | ||
| Fatigue Scores at 1, 4, and 8 Hours Post Tilt Table Testing | CPC Adminstration | Fatigue rated at 1 hour post tilt test | 2.2 | Standard Deviation 1.05 | Score on a scale |
| Fatigue Scores at 1, 4, and 8 Hours Post Tilt Table Testing | Placebo Administration | Fatigue rated at 1 hour post tilt test | 2.0 | Standard Deviation 0.85 | Score on a scale |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CPC Adminstration | 66 | |
| Overall Study | STARTED | Placebo Adminstration | 63 | |
| Overall Study | Primary Analysis Population | CPC Adminstration | 65 | |
| Overall Study | Primary Analysis Population | Placebo Adminstration | 62 | |
| Overall Study | Secondary Analysis Population | CPC Adminstration | 32 | |
| Overall Study | Secondary Analysis Population | Placebo Adminstration | 27 | |
| Overall Study | COMPLETED | CPC Adminstration | 66 | |
| Overall Study | COMPLETED | Placebo Adminstration | 63 | |
| Overall Study | NOT COMPLETED | CPC Adminstration | 0 | |
| Overall Study | NOT COMPLETED | Placebo Adminstration | 0 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain upper | Gastrointestinal disorders | CPC Adminstration | 2 | 66 | 2 |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo Administration | 0 | 63 | 0 |
| other | Nausea | Gastrointestinal disorders | CPC Adminstration | 1 | 66 | 1 |
| other | Nausea | Gastrointestinal disorders | Placebo Administration | 0 | 63 | 0 |
| other | Headache | Nervous system disorders | CPC Adminstration | 1 | 66 | 1 |
| other | Headache | Nervous system disorders | Placebo Administration | 3 | 63 | 3 |
| other | Migraine Headache | Nervous system disorders | CPC Adminstration | 0 | 66 | 0 |
| other | Migraine Headache | Nervous system disorders | Placebo Administration | 1 | 63 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CPC Adminstration | 0 | 66 |
| Total, all-cause mortality | Placebo Administration | 0 | 63 |
| Total, other adverse events | CPC Adminstration | 3 | 66 |
| Total, other adverse events | Placebo Administration | 4 | 63 |
| Total, serious adverse events | CPC Adminstration | 0 | 66 |
| Total, serious adverse events | Placebo Administration | 0 | 63 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 11194602 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| CPC Administration vs Placebo Administration: Percentage of Patients Who Have Asystolic Pauses > 3 Seconds in the CPC and Placebo Arms | Trial comparisons |
| CPC Adminstration vs Placebo Administration: deaths from any cause | Trial comparisons |
| CPC Adminstration vs Placebo Administration: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04972123
GET https://conductscience.org/api/trials/v1/NCT04972123/registered