Ambulatory Blood Pressure Monitoring in Rivaroxaban Therapy | NCT02539953

Studies
Ambulatory Blood Pressure Monitoring in Rivaroxaban Therapy

NCT02539953

Sponsor

King's College Hospital NHS Trust

Status

Withdrawn

Last Update Posted

Aug 12, 2020Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Hypotension

Interventions

Ambulatory blood pressure monitoring

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2015

Primary Completion Date

Sep 2015Estimated

Completion Date

Not provided

First Submitted Date

Sep 1, 2015

First Submission Date that Met QC Criteria

Sep 2, 2015

First Posted Date

Sep 3, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 10, 2020

Last Update Posted Date

Aug 12, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ambulatory blood pressure monitoring	Device	Patients with dizziness on taking rivaroxaban will have ambulatory blood pressure monitoring to assess haemodynamic effects indirectly

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Average blood pressure readings		48 hours

Secondary Outcomes

Measure	Description	Time Frame
Correlation of blood pressure readings to rivaroxaban dosing		48 hours
Correlation of blood pressure readings to symptomatology		48 hours

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Roopen Arya, MBChB FRCP	King's College Hospital NHS Trust	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kings College Hospital NHS Foundation Trust		London		SE5 9RS	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D007022	Hypotension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D018660	Blood Pressure Monitoring, Ambulatory

Ancestor Terms

ID	Term
D001795	Blood Pressure Determination
D003935	Diagnostic Techniques, Cardiovascular
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided