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Ambulatory Blood Pressure Monitoring in Rivaroxaban Therapy

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02539953
Enrollment
0
Registered
2015-09-03
Start date
2015-04-30
Completion date
Unknown
Last updated
2020-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension

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.

Interventions

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

Sponsors

King's College Hospital NHS Trust
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frame
Average blood pressure readings48 hours

Secondary

MeasureTime frame
Correlation of blood pressure readings to rivaroxaban dosing48 hours
Correlation of blood pressure readings to symptomatology48 hours

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026