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

Atrial Fibrillation Clinical Trial

— EQUAL-AF  

Official title:

Evaluating QUAlity of Life of AF Patients Following a Bleed (EQUAL-AF)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05044533
• Other study ID #: CV185-770
• Status: Completed
• Start date: May 31, 2021
• Est. completion date: March 9, 2022

Study information

• Verified date: June 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 9, 2022
• Est. primary completion date: March 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
United Kingdom	Local Institution - 0001	Swansea

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distribution of characteristics of AF participants: Quality of life (QoL) data		Up to 90 days
Primary	Distribution of characteristics of AF participants: Impact of the anticoagulation treatment		Up to 90 days
Secondary	Distribution of outcomes of AF participants: Timing of bleeding occurrence		Up to 90 days
Secondary	Distribution of outcomes of AF participants: Nature of the bleed		Up to 90 days
Secondary	Distribution of outcomes of AF participants: Current Bleeding treatment		Up to 90 days
Secondary	Distribution of outcomes of AF participants: Location of bleed		Up to 90 days
Secondary	Distribution of outcomes of AF participants: Documented cause of bleed		Up to 90 days

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls