A Study Evaluating Quality of Life for Participants With... | NCT05044533

Studies
A Study Evaluating Quality of Life for Participants With Atrial Fibrillation (AF) Following a Bleed (EQUAL-AF)

NCT05044533

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Jun 18, 2023Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

Not provided

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

Jun 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 31, 2021Actual

Primary Completion Date

Mar 9, 2022Actual

Completion Date

Mar 9, 2022Actual

First Submitted Date

Sep 10, 2021

First Submission Date that Met QC Criteria

Sep 10, 2021

First Posted Date

Sep 14, 2021Actual

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

Jun 15, 2023

Last Update Posted Date

Jun 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

The purpose of this observational study is to identify participants with both minor and major bleeds as a result of anticoagulant treatment for AF and evaluating their QoL through both primary and secondary care settings.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Label	Type	Description	Intervention Names
Cohort 1		Participants with atrial fibrillation (AF) experiencing a bleed

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Distribution of characteristics of AF participants: Quality of life (QoL) data		Up to 90 days
Distribution of characteristics of AF participants: Impact of the anticoagulation treatment		Up to 90 days

Secondary Outcomes

Measure	Description	Time Frame
Distribution of outcomes of AF participants: Timing of bleeding occurrence		Up to 90 days
Distribution of outcomes of AF participants: Nature of the bleed		Up to 90 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

Adult patients (>= 18 years old)
Patients who can understand all study information and literature to provide fully informed consent
Atrial fibrillation (AF) as the primary diagnosis
Having a major or minor bleed up to a maximum of 30 days prior to point of enrolment
Receiving oral anticoagulation therapy for AF

Exclusion Criteria:

Pregnant women
Patients with active cancer
Patients unable to consent for themselves
Patient on concomitant antiplatelet therapy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients (≥18) who have Atrial fibrillation (AF) and are actively prescribed oral anticoagulant therapies (OATs) and have recently experienced bleeds, up to a maximum of 30 days prior to enrolment. No upper age limit will be applied, but patients must match all other inclusion/exclusion criteria.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution - 0001		Swansea		SA2 8PP	United Kingdom

References Module

Citations

Not provided

Label	URL
BMS Clinical Trial Information	View source
Investigator Inquiry Form	View source
FDA Safety Alerts and Recalls

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes