Ambulatory Blood Pressure Monitoring in Rivaroxaban Therapy
Not Applicable
Withdrawn
- Conditions
- Hypotension
- Registration Number
- NCT02539953
- Lead Sponsor
- King's College Hospital NHS Trust
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Average blood pressure readings 48 hours
- Secondary Outcome Measures
Name Time Method Correlation of blood pressure readings to rivaroxaban dosing 48 hours Correlation of blood pressure readings to symptomatology 48 hours
Trial Locations
- Locations (1)
Kings College Hospital NHS Foundation Trust
🇬🇧London, United Kingdom