Back to resultsAmbulatory Blood Pressure Monitoring in Rivaroxaban Therapy
Primary Purpose
Hypotension
Status
Withdrawn
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Ambulatory blood pressure monitoring
Sponsored by
About this trial
This is an interventional diagnostic trial for Hypotension
Eligibility Criteria
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
Sites / Locations
- Kings College Hospital NHS Foundation Trust
Outcomes
Primary Outcome Measures
Average blood pressure readings
Secondary Outcome Measures
Correlation of blood pressure readings to rivaroxaban dosing
Correlation of blood pressure readings to symptomatology
Full Information
NCT ID
NCT02539953
First Posted
September 1, 2015
Last Updated
August 10, 2020
Sponsor
King's College Hospital NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT02539953
Brief Title
Ambulatory Blood Pressure Monitoring in Rivaroxaban Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Withdrawn
Study Start Date
April 2015 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College Hospital NHS Trust
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Ambulatory blood pressure monitoring
Intervention Description
Patients with dizziness on taking rivaroxaban will have ambulatory blood pressure monitoring to assess haemodynamic effects indirectly
Primary Outcome Measure Information:
Title
Average blood pressure readings
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Correlation of blood pressure readings to rivaroxaban dosing
Time Frame
48 hours
Title
Correlation of blood pressure readings to symptomatology
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roopen Arya, MBChB FRCP
Organizational Affiliation
King's College Hospital NHS Trust
Official's Role
Study Chair
Facility Information:
Facility Name
Kings College Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Ambulatory Blood Pressure Monitoring in Rivaroxaban Therapy
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