At a glance
ClinicalIndex Comparison RecordN/ACompleted· 1,506 enrolled
Drug / intervention
Dabigatran etexilate +1 moredrug
Likely dose
Dabigatran etexilate 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Drug Persistence/Adherence in Patients Being Treated With Dabigatran Etexilate or VKA for Stroke Prevention in Non-valvular Atrial Fibrillation (SPAF)
In Brief
An observational study evaluating Dabigatran etexilate and Vitamin K antagonists for Atrial Fibrillation. Completed, enrolled 1,506 participants across 1 site.
Detailed 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.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation
CountriesGermany
Collaborators--
Timeline
N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 2014
Enrollment StartSep 2014
Primary CompletionDec 2017
TodayJul 2026
First PostedSep 16, 2014
Enrollment StartSep 18, 2014
Primary CompletionDec 31, 2017
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 11.8 years ago
Interventions
Dabigatran etexilatedrug
150 mg or 110 mg capsules twice daily
Vitamin K antagonistsdrug
International Normalized Ratio (INR) 2-3