Clinical trial NCT02839746: Treatment Convenience in Patients Treated With Dabigatran for Stroke Prophylaxis in Atrial Fibrillation (SPAF)
Official title: Non-interventional Study Describing Treatment Convenience in Patients Treated With Dabigatran for Stroke Prophylaxis in Atrial Fibrillation (SPAF)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2016-07-21
Enrollment: 671
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: spanish patients with a diagnosis of non-valvular atrial fibrillation

Brief summary: Describe patient and physician assessed factors for patient well-being when treated with Pradaxa for stroke and embolism prevention in atrial fibrillation either compared to previous antithrombotic treatment (switcher)


Eligibility criteria: Inclusion criteria:

* Written informed consent prior to participation
* Female and male patients 18 years of age or older with a diagnosis of non-valvular atrial fibrillation.
* At least 6 months of continuous vitamin K antagonist (VKA) treatment for stroke prevention prior to baseline assessment.
* Patients switched to Pradaxa® according to Summary of Product Characteristics, therapeutic positioning report from Spanish competent authorities and visa from each autonomous community.

Exclusion criteria:

* Contraindication to the use of Pradaxa® or VKA as described in the Summary of Product Characteristics (SmPC)
* Patients receiving Pradaxa® or VKA for any other condition than stroke prevention in non-valvular atrial fibrillation.
* Current participation in any clinical trial of a drug or device

Primary outcomes:
measure: Mean of Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores at Second Assessment Compared to Baseline Assessment
timeFrame: When planned to be switched from VKA to Pradaxa® (At baseline, Visit 1), 7 to 124 days after starting treatment with Pradaxa® (initiation period, Visit 2)
measure: Mean of Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores at Last Assessment Compared to Baseline Assessment
timeFrame: When planned to be switched from VKA to Pradaxa® (At baseline, Visit 1), 125 to 365 days after starting treatment with Pradaxa® (continuation period, Visit 3)
measure: Mean of Perception of Anticoagulant Treatment Questionnaire (PACT-Q2) Score at Last Assessment Compared to Second Assessment
timeFrame: 7 to 124 days after starting treatment with Pradaxa® (initiation period, Visit 2), 125 to 365 days after starting treatment with Pradaxa® (continuation period, Visit 3)
Secondary outcomes:
measure: Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score and HAS-BLED Bleeding Risk Score
timeFrame: Baseline
measure: Patient Characteristics at Baseline - Categorical Parameters
timeFrame: Baseline
measure: Patient Characteristics at Baseline - Creatinine Clearance
timeFrame: Baseline
measure: Patient Characteristics at Baseline - Vitamin K Antagonist Treatment Duration
timeFrame: Baseline
measure: Patient Characteristics at Baseline - Reasons for Switching From VKAs to Pradaxa®
timeFrame: Baseline
measure: Reason for Changing the Dose of Pradaxa®: 150 mg/ Twice Daily (Bid) to 110 mg/Bid
timeFrame: 7 to 124 days after starting treatment with Pradaxa® (initiation period, Visit 2), 125 to 365 days after starting treatment with Pradaxa® (continuation period, Visit 3)
measure: Reason for Changing the Dose of Pradaxa®: 110 mg/Bid to 150 mg/Bid
timeFrame: 7 to 124 days after starting treatment with Pradaxa® (initiation period, Visit 2), 125 to 365 days after starting treatment with Pradaxa® (continuation period, Visit 3)
measure: Reasons for no Longer Receiving Pradaxa® Treatment
timeFrame: 7 to 124 days after starting treatment with Pradaxa® (initiation period, Visit 2), 125 to 365 days after starting treatment with Pradaxa® (continuation period, Visit 3)
Other outcomes:
Locations:
city: Multiple Locations
country: Spain
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: