Drug Persistence/Adherence in Patients Treated With Dabigatran or VKA for Stroke Prevention in Non Valvular Atrial Fibrillation (SPAF)

Boehringer Ingelheim

Status

Completed

Conditions

Atrial Fibrillation

Treatments

Drug: Dabigatran etexilate

Drug: Vitamin K antagonists

Study type

Observational

Funder types

Industry

Identifiers

NCT02240667

1160.218

Details and patient eligibility

About

1600 AF patients receiving Pradaxa or VKA for stroke prevention will be followed up for 12 months in quarterly visits. Prescriptions, adverse events and (if applicable) reasons for definitive treatment discontinuation will be collected. At 6 months, patient adherence will be assessed, using the Morisky Score.

Enrollment

1,506 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Newly prescribed treatment with Pradaxa® (dabigatran etexilate)/VKA in the indication "Stroke prevention in non-valvular atrial fibrillation" (AF) respecting the indication and contraindications as described in the respective Summary of Product Characteristics for Pradaxa® 110 mg or 150 mg hard capsules or the appropriate VKA (patients are eligible for both Pradaxa® and VKA therapy).
Treatment with dabigatran etexilate or VKA is given in accordance with the respective Summaries of Product Characteristics. The routine diagnostic procedures and treatment that would be undertaken irrespective of the study are unaffected.
Only patients who are eligible both for therapy with Pradaxa® and for therapy with VKA in accordance with the respective Summaries of Product Characteristics will be documented (patients eligible for VKA and Pradaxa®)
Patients must have signed the patient consent form prior to inclusion in the Non-Interventional Study (NIS).

Exclusion criteria

Patients with the general and special contraindications mentioned in the packaging leaflet or Summary of Product Characteristics must not be included.
Patients participating at the same time or within the last 30 days in another Non-Interventional Study (NIS) or an interventional clinical trial must not be included.
Patients treated with anticoagulants for a condition other than non-valvular atrial fibrillation must not be included.
Pradaxa® and VKA should not be used during pregnancy and lactation. Pregnant or breastfeeding women must therefore not be included in the NIS.