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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

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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

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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.

ListOutcomeTime frameDescription
PrimaryPercentage of Participants Who Have Hypotensive Syncope or Near Syncope With SBP Less Than or Equal to 70 mmHG During Tilt TestDuring 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.
PrimaryTime to Syncope or Near-syncope After CPC or Placebo AdministrationDuring 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
SecondaryPercentage of Patients Who Have Asystolic Pauses > 3 Seconds in the CPC and Placebo ArmsDuring 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
SecondaryFatigue Scores at 1, 4, and 8 Hours Post Tilt Table TestingUp 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.

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYPercentage of Participants Who Have Hypotensive Syncope or Near Syncope With SBP Less Than or Equal to 70 mmHG During Tilt TestDuring tilt table testing (up to approximately 35 minutes)Intention to treat based on randomized treatment assignmentParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYTime to Syncope or Near-syncope After CPC or Placebo AdministrationDuring tilt table testing (up to approximately 35 minutes)Secondary endpoints analyses were limited to participants who had syncope or near syncopesecondsMEDIAN
SECONDARYPercentage of Patients Who Have Asystolic Pauses > 3 Seconds in the CPC and Placebo ArmsDuring tilt table testing (up to approximately 35 minutes)Secondary endpoints analyses were limited to participants who had syncope or near syncopeParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYFatigue Scores at 1, 4, and 8 Hours Post Tilt Table TestingUp 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 syncopeScore on a scaleMEDIAN

Results by group14

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Percentage of Participants Who Have Hypotensive Syncope or Near Syncope With SBP Less Than or Equal to 70 mmHG During Tilt TestCPC AdminstrationNumber of participants with syncope or near syncope event32Participants
Percentage of Participants Who Have Hypotensive Syncope or Near Syncope With SBP Less Than or Equal to 70 mmHG During Tilt TestPlacebo AdministrationNumber of participants with syncope or near syncope event27Participants
Percentage of Participants Who Have Hypotensive Syncope or Near Syncope With SBP Less Than or Equal to 70 mmHG During Tilt TestCPC AdminstrationNumber of participants without syncope or near syncope event33Participants
Percentage of Participants Who Have Hypotensive Syncope or Near Syncope With SBP Less Than or Equal to 70 mmHG During Tilt TestPlacebo AdministrationNumber of participants without syncope or near syncope event35Participants
Time to Syncope or Near-syncope After CPC or Placebo AdministrationCPC Administration90.1Standard Deviation 95.0seconds
Time to Syncope or Near-syncope After CPC or Placebo AdministrationPlacebo Administration76.9Standard Deviation 95.0seconds
Percentage of Patients Who Have Asystolic Pauses > 3 Seconds in the CPC and Placebo ArmsCPC Administration2Participants
Percentage of Patients Who Have Asystolic Pauses > 3 Seconds in the CPC and Placebo ArmsPlacebo Administration1Participants
Fatigue Scores at 1, 4, and 8 Hours Post Tilt Table TestingCPC AdminstrationFatigue rated at 1 hour post tilt test2.2Standard Deviation 1.05Score on a scale
Fatigue Scores at 1, 4, and 8 Hours Post Tilt Table TestingPlacebo AdministrationFatigue rated at 1 hour post tilt test2.0Standard Deviation 0.85Score on a scale

Participant flow10

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDCPC Adminstration66
Overall StudySTARTEDPlacebo Adminstration63
Overall StudyPrimary Analysis PopulationCPC Adminstration65
Overall StudyPrimary Analysis PopulationPlacebo Adminstration62
Overall StudySecondary Analysis PopulationCPC Adminstration32
Overall StudySecondary Analysis PopulationPlacebo Adminstration27
Overall StudyCOMPLETEDCPC Adminstration66
Overall StudyCOMPLETEDPlacebo Adminstration63
Overall StudyNOT COMPLETEDCPC Adminstration0
Overall StudyNOT COMPLETEDPlacebo Adminstration0

Adverse events8

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherAbdominal pain upperGastrointestinal disordersCPC Adminstration2662
otherAbdominal pain upperGastrointestinal disordersPlacebo Administration0630
otherNauseaGastrointestinal disordersCPC Adminstration1661
otherNauseaGastrointestinal disordersPlacebo Administration0630
otherHeadacheNervous system disordersCPC Adminstration1661
otherHeadacheNervous system disordersPlacebo Administration3633
otherMigraine HeadacheNervous system disordersCPC Adminstration0660
otherMigraine HeadacheNervous system disordersPlacebo Administration1631

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityCPC Adminstration066
Total, all-cause mortalityPlacebo Administration063
Total, other adverse eventsCPC Adminstration366
Total, other adverse eventsPlacebo Administration463
Total, serious adverse eventsCPC Adminstration066
Total, serious adverse eventsPlacebo Administration063

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
11194602BACKGROUND

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.

ComparisonSource
CPC Administration vs Placebo Administration: Percentage of Patients Who Have Asystolic Pauses > 3 Seconds in the CPC and Placebo ArmsTrial comparisons
CPC Adminstration vs Placebo Administration: deaths from any causeTrial comparisons
CPC Adminstration vs Placebo Administration: serious adverse eventsTrial 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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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