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Clinical Trials/NCT02539953
NCT02539953WithdrawnNot Applicable

Ambulatory Blood Pressure Monitoring in Rivaroxaban Therapy

King's College Hospital NHS Trust1 site in 1 countryStarted: April 1, 2015Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Sponsor
Locations
1
Primary Endpoint
Average blood pressure readings
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

One in ten patients on rivaroxaban therapy have dizziness and reductions in blood pressure. The investigators intend to monitor the ambulatory blood pressure of such patients in order to assess whether this is a true haemodynamic effect.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Aged 18-75 years
  • •Able to provide written, informed consent
  • •Taking rivaroxaban for any indication within the license of the drug, both once daily and twice daily dosing can be included
  • •Have measurable rivaroxaban levels on at least one occasion (this will be in line with standard of care, there will be no extra blood samples for the study)
  • •Not taking concomitant medication that can affect rivaroxaban metabolism (including amiodarone, dronedarone, -azole antifungals, protease inhibitors)
  • •On no antihypertensive or vasoactive medication
  • •Have a baseline BP recording taken in clinic

Exclusion Criteria

  • •Unable to provide written, informed consent
  • •Presence of concomitant medication that may alter rivaroxaban levels and confound results (see above)
  • •Unwilling to undergo ambulatory blood pressure monitoring
  • •Contraindication to ambulatory blood pressure monitoring

Outcomes

Primary Outcomes

Average blood pressure readings

Time Frame: 48 hours

Secondary Outcomes

  • Correlation of blood pressure readings to rivaroxaban dosing(48 hours)
  • Correlation of blood pressure readings to symptomatology(48 hours)

Investigators

Sponsor
King's College Hospital NHS Trust
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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