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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1506 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-18

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Subjects with atrial fibrillation

Dabigatran etexilate

Intervention Type DRUG

150 mg or 110 mg capsules twice daily

Vitamin K antagonists

Intervention Type DRUG

International Normalized Ratio (INR) 2-3

Interventions

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Dabigatran etexilate

150 mg or 110 mg capsules twice daily

Intervention Type DRUG

Vitamin K antagonists

International Normalized Ratio (INR) 2-3

Intervention Type DRUG

Other Intervention Names

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Phenprocoumon

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No