Ambulatory Blood Pressure Monitoring in Rivaroxaban Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypotension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Ambulatory blood pressure monitoring

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No