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

NCT05044533 | Completed

• 1 other identifier: CV185-770
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

BMS-562247; Atrial Fibrillation; Oral Anticoagulant; Prospective Study; Quality of Life (QoL); United Kingdom

Outcome Measures

Primary Outcomes (2)

• 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 (5)

• 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

• Distribution of outcomes of AF participants: Current Bleeding treatment

  Up to 90 days

• Distribution of outcomes of AF participants: Location of bleed

  Up to 90 days

• Distribution of outcomes of AF participants: Documented cause of bleed

  Up to 90 days

Study Arms (1)

Cohort 1

Participants with atrial fibrillation (AF) experiencing a bleed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution - 0001

Swansea, SA2 8PP, United Kingdom

Location

Related Links

• BMS Clinical Trial Information
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: September 14, 2021
• Study Start: May 31, 2021
• Primary Completion: March 9, 2022
• Study Completion: March 9, 2022
• Last Updated: June 18, 2023

Record last verified: 2023-06

Locations

GB (1)