Health-related Quality of Life in Patients on Anticoagulants (RE-QUOL)

Boehringer Ingelheim

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Drug: VKA; Drug: DOAC or VKA

Study type: Observational

Funder types: Industry

Identifiers

NCT03134911

1160-0280

Details and patient eligibility

About

The present study has been designed to describe the health-related quality of life in patients with non valvular atrial fibrillation who have been prescribed a specific anticoagulant treatment for their non valvular atrial fibrilation at least 6 months prior to study initiation. It will be conducted in Departments of Internal Medicine from approximately 50 centers in Spain. It consists of an only visit that will coincide with one of those performed by the patients as part of routine follow-up of their disease. 500 patients seen in internal medicine are planned to be included in the study

Enrollment: 535 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient is willing and provides written informed consent to participate in this study.
• The patient is at least 18 years of age
• The patient has a diagnosis of non-valvular atrial fibrillation
• The patient is on the same anticoagulant therapy (VKA or DOAC) during at least 6 months and maximum 2 years.
• If treated with VKA, availability of % Time in Therapeutic Range (TTR) in past analytical records or enough amount of International Normalized Ratio (INR) measures to calculate it.

Exclusion criteria

• Current participation in any clinical trial of a drug or device
• Contraindication to the use of DOAC or VKA as described in the Summary of Product Characteristics (SmPC).

Trial design

535 participants in 2 patient groups

anticoagulation controlled patients

Description:

Treated with DOAC or VKA

Treatment:

Drug: DOAC or VKA

anticoagulation non controlled patients

Description:

Treated with VKA

Treatment:

Drug: VKA