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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02240667
• Other study ID #: 1160.218
• Status: Completed
• Start date: September 18, 2014
• Est. completion date: December 31, 2017

Study information

• Verified date: April 2019
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1506
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Dabigatran etexilate
150 mg or 110 mg capsules twice daily
• Vitamin K antagonists
International Normalized Ratio (INR) 2-3

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients Treated With Anticoagulation Initially Started at the 12 Month	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.	12 month (Visit 5)
Secondary	Percentage of Patients With Low, Medium or High Adherence at the Timepoint of 6 Months-visit.	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).	6 month (visit 3)
Secondary	Number of Patients With the Reason for Definitive Treatment Discontinuation	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)

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