NCT02539953

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2015

Completed
Last Updated

August 12, 2020

Status Verified

February 1, 2015

Enrollment Period

5 months

First QC Date

September 1, 2015

Last Update Submit

August 10, 2020

Conditions

Hypotension

Outcome Measures

Primary Outcomes (1)

  • Average blood pressure readings

    48 hours

Secondary Outcomes (2)

  • Correlation of blood pressure readings to rivaroxaban dosing

    48 hours

  • Correlation of blood pressure readings to symptomatology

    48 hours

Interventions

Ambulatory blood pressure monitoringDEVICE

Patients with dizziness on taking rivaroxaban will have ambulatory blood pressure monitoring to assess haemodynamic effects indirectly

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kings College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Hypotension

Interventions

Blood Pressure Monitoring, Ambulatory

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Blood Pressure DeterminationDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisMonitoring, AmbulatoryMonitoring, Physiologic

Study Officials

  • Roopen Arya, MBChB FRCP

    King's College Hospital NHS Trust

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2015

First Posted

September 3, 2015

Study Start

April 1, 2015

Primary Completion

September 1, 2015

Last Updated

August 12, 2020

Record last verified: 2015-02

Locations

GB(1)