Anticoagulation Preference by AF Patients Study

Atrial Fibrillation Clinical Trial

— PRiSMA-AF  

Official title:

AF Patient Preferences Towards NOAC Versus VKA Treatment: a Patient Preference Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02607371
• Other study ID #: 18242
• Status: Completed
• Phase: N/A
• First received: August 27, 2015
• Last updated: September 13, 2017
• Start date: August 27, 2015
• Est. completion date: October 15, 2016

Study information

• Verified date: September 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The main research question of this patient survey is to assess AF (Atrial Fibrillation) patients' preferences associated with different attributes which describe the different available anticoagulation treatment options (Vitamin K Antagonists [VKA] or New Oral Anticoagulants [NOACs] and, in case of NOACs, Apixaban, Dabigatran, Edoxaban or Rivaroxaban).

VKAs (Marcoumar®, Sintrom ®) will be grouped together and compared to Rivaroxaban.

Description:

The objective of this study is to investigate the following research questions in a cross-sectional survey of German-speaking Swiss AF patients being treated either with a VKA or with a NOAC:

• Which attributes of a medication to prevent stroke do AF patients view as important?

• Do AF patients have a preference regarding the attributes of the medication options VKA or NOAC and, in case of NOACs, with regards to rivaroxaban attributes?

• Are there subgroups of AF patients whose preference for one of the medication options appears above or below average?

• What is the quality of life of Swiss German-speaking AF patients? Are there subgroups with differences in their quality of life (for example: subgroups of patients with different CHA2DS2-VASc scores)?

• Which burden do German-speaking Swiss AF patients experience in association with their anticoagulation therapy? Are there differences in the burden of treatment (ACTS) between patients treated with VKA or with NOACs?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: October 15, 2016
• Est. primary completion date: October 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Inclusion criteria for AF patients in both the NOAC and the VKA groups:

• Patients with a confirmed diagnosis of nonvalvular atrial fibrillation (persistent, paroxysmal, permanent),

• Age of at least 18 years at time of study inclusion,

• Generally willingness (informed consent) and ability to fill out a survey on satisfaction with treatment and quality of life, and to conduct a structured phone interview (approx. 20 - 30 min) in German language.

Additional inclusion criterion for Group 1 (NOAC):

• Continuous anticoagulation with either Apixaban, or Dabigatran or Rivaroxaban for prevention of Stroke & systemic embolism for at least the previous 3 months.

Additional inclusion criterion for Group 2 (VKA):

• Continuous anticoagulation with a VKA for prevention of Stroke & systemic embolism for at least the previous 3 months.

Exclusion Criteria:

Exclusion criteria for both groups:

• Participation in another study (clinical intervention / observational) within the 3 months prior to enrollment,

• Interruption of VKA/NOAC therapy of more than 2 weeks (bridging) within the prior 3 months or planned bridging in 4 weeks after study inclusion.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Other:
• VKAs
VKA have been prescribed in the customary manner in accordance with the terms of the marketing authorization; decision to prescribe these agents has been made at least 3 months prior to study inclusion; assignment of a patient to a particular therapeutic strategy is only made retrospectively (treatment decision falls within current practice and the prescription of the medicines is separated from the decision to include the patient in the study)
• NOACs including Rivaroxaban (Xarelto, BAY59-7939)
NOAC have been prescribed in the customary manner in accordance with the terms of the marketing authorization; decision to prescribe these agents has been made at least 3 months prior to study inclusion; assignment of a patient to a particular therapeutic strategy is only made retrospectively (treatment decision falls within current practice and the prescription of the medicines is separated from the decision to include the patient in the study)
• Edoxaban
NOAC have been prescribed in the customary manner in accordance with the terms of the marketing authorization; decision to prescribe these agents has been made at least 3 months prior to study inclusion; assignment of a patient to a particular therapeutic strategy is only made retrospectively (treatment decision falls within current practice and the prescription of the medicines is separated from the decision to include the patient in the study)
• Apixaban
NOAC have been prescribed in the customary manner in accordance with the terms of the marketing authorization; decision to prescribe these agents has been made at least 3 months prior to study inclusion; assignment of a patient to a particular therapeutic strategy is only made retrospectively (treatment decision falls within current practice and the prescription of the medicines is separated from the decision to include the patient in the study)
• Dabigatran-etexilate
NOAC have been prescribed in the customary manner in accordance with the terms of the marketing authorization; decision to prescribe these agents has been made at least 3 months prior to study inclusion; assignment of a patient to a particular therapeutic strategy is only made retrospectively (treatment decision falls within current practice and the prescription of the medicines is separated from the decision to include the patient in the study)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AF patients`preferences towards anticoagulation treatment with either VKAs or NOACs measured with a DCE (discrete choice experiment) design in a phone interview	DCE is based on the following attributes /attribute levels: Frequency of intake (once/twice daily),; Need of INR monitoring/dose adjustment (yes/no),; Need of bridging (yes/no),; Interactions with food/drugs (yes/no),; Distance to treating physician (1km or 15km).	up to 4 weeks
Secondary	Burden associated with anticoagulation treatment measured by the questionnaire ACTS		Baseline
Secondary	Health-related quality of life measured by the SF-12 questionnaire	Variables: Physical/psychological domain according to SF-12 questionnaire	up to 4 weeks
Secondary	Assessment of factors that may be associated with AF patients preferences towards a specific anticoagulation treatment: preferred anticoagulation treatment (agent)		up to 4 weeks
Secondary	Assessment of factors that may be associated with AF patients preferences towards a specific anticoagulation treatment: HrQoL as defined by the SF-12 score		up to 4 weeks
Secondary	Assessment of factors that may be associated with AF patients preferences towards a specific anticoagulation treatment: AF symptoms as measured by the EHRA		up to 4 weeks
Secondary	Assessment of factors that may be associated with AF patients preferences towards a specific anticoagulation treatment: TTR (for VKA patients only)		up to 4 weeks
Secondary	Assessment of factors that may be associated with AF patients preferences towards a specific anticoagulation treatment: Age		up to 4 weeks
Secondary	Assessment of factors that may be associated with AF patients preferences towards a specific anticoagulation treatment: Gender		up to 4 weeks

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