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

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: Dabigatran etexilate; Drug: Vitamin K antagonists

• Registration Number: NCT02240667
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-15
• Study First Submitted QC: 2014-09-15
• Study First Posted: 2014-09-16
• Study Start: 2014-09-18
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Results First Submitted: 2018-12-20
• Status Verified: 2019-04
• Results First Submitted QC: 2019-04-18
• Last Update Submitted: 2019-04-18
• Results First Posted: 2019-04-19
• Last Update Posted: 2019-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1506

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects with atrial fibrillation	Vitamin K antagonists	-
Subjects with atrial fibrillation	Dabigatran etexilate	-

Primary Outcome Measures

Name	Time	Method
Percentage of Patients Treated With Anticoagulation Initially Started at the 12 Month	12 month (Visit 5)	Percentage of patients treated with the initially allocated anticoagulant at the 12-month visit, defined as Kaplan Meier estimate at 12 months for persistence, stratified for dabigatran etexilate and VKA.Persistence is defined as the time between initiation and permanent discontinuation of therapy. The initiation date is the documented start of treatment (at visit 1), and the date of permanent discontinuation is the documented permanent discontinuation of dabigatran etexilate or VKA therapy.

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients With Low, Medium or High Adherence at the Timepoint of 6 Months-visit.	6 month (visit 3)	Percentage of patients with low, medium or high adherence at the 6-month visit, stratified for dabigatran etexilate and VKA; categorisation is done on the basis of the Morisky questionnaire (high, medium and low adherence with a Morisky score of 0, 1 to 2, and \> 2, respectively).
Number of Patients With the Reason for Definitive Treatment Discontinuation	Visit 2, 3, 4 and 5 (after approx. 3, 6, 9 and 12 months of treatment)	Number of patients with the reason for definitive treatment discontinuation