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NCT02539953 Clinical Trial

Ambulatory Blood Pressure Monitoring in Rivaroxaban Therapy

Hypotension Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02539953
Other study ID # KCH1002
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date April 2015

Study information
Verified date February 2015
Source King's College Hospital NHS Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United Kingdom Kings College Hospital NHS Foundation Trust London

Sponsors (1)
Lead Sponsor Collaborator
King's College Hospital NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Average blood pressure readings 48 hours
Secondary Correlation of blood pressure readings to rivaroxaban dosing 48 hours
Secondary Correlation of blood pressure readings to symptomatology 48 hours
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