Patients' Assessment of Satisfaction for Stroke Prevention in Atrial Fibrillation

Boehringer Ingelheim

Status

Completed

Conditions

Atrial Fibrillation

Treatments

Drug: Pradaxa®

Study type

Observational

Funder types

Industry

Identifiers

NCT03187197

1160-0286

Details and patient eligibility

About

To describe the treatment perception from patients with non-valvular atrial fibrillation (NVAF) receiving Pradaxa® or VKA for stroke prevention by using the self-estimation questionnaire of PACT-Q during a 6-month study period.

Enrollment

1,315 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Cohort A (patients switched from VKA to Pradaxa)

Written informed consent prior to participation.
Female or male patients ≥ 20 years of age with a diagnosis of non-valvular atrial fibrillation (NVAF).
At least 3 months of continuous VKA treatment for stroke prevention prior to baseline assessment.
Patients switched to Pradaxa prior to baseline assessment according to the physician's discretion and the Summary of Product Characteristics (SmPCs)/reimbursement criteria.

OR Cohort B (patients newly initiated Pradaxa or VKA)

Written informed consent prior to participation.
Female or male patients ≥ 20 years of age, newly diagnosed with NVAF, and no previous treatment for stroke prevention (no use of any OAC within 1 year prior to enrolment).
Patients initiated stroke prevention treatment with Pradaxa or VKA according to the physician's discretion and the SmPCs/reimbursement criteria.

Exclusion criteria

Contraindication to the use of Pradaxa® or VKA as described in the SmPCs.
Patients receiving Pradaxa® or VKA for any other condition than stroke prevention in NVAF.
Current participation in any clinical trial of a drug or device.
Current participation in an AF-related registry, e.g. the Gloria AF program.