Clinical trial NCT02240667: Drug Persistence/Adherence in Patients Treated With Dabigatran or VKA for Stroke Prevention in Non Valvular Atrial Fibrillation (SPAF)
Official title: Drug Persistence/Adherence in Patients Being Treated With Dabigatran Etexilate or VKA for Stroke Prevention in Non-valvular Atrial Fibrillation (SPAF)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-16
Enrollment: 1506
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: AF patients

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Patients Treated With Anticoagulation Initially Started at the 12 Month
timeFrame: 12 month (Visit 5)
Secondary outcomes:
measure: Percentage of Patients With Low, Medium or High Adherence at the Timepoint of 6 Months-visit.
timeFrame: 6 month (visit 3)
measure: Number of Patients With the Reason for Definitive Treatment Discontinuation
timeFrame: Visit 2, 3, 4 and 5 (after approx. 3, 6, 9 and 12 months of treatment)
Other outcomes:
Locations:
city: Multiple Locations
country: Germany
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: