Trial Condition(s):
Atrial Fibrillation
Xarelto Evidence in Real Life of Patients’ Preference and Satisfaction Study (X-PRESS)
Bayer Identifier:
18728
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
The main objective of the study is to assess preferences of Non Valvular Atrial Fibrillation (NVAF) patients towards different options of an anticoagulation treatment.
Patient preferences for anticoagulant treatment attributes (convenience attributes only), based on a Discrete Choice Experiment(DCE) interview will be elicited and the impact of switching from Vitamin K Antagonist(VKA) to Xarelto® on Atrial Fibrilation(AF) patient treatment satisfaction will be documented, measured by score differences of the Anti-Clot Treatment Scale (ACTS) score in patients switching from VKA to Rivaroxaban.
Inclusion Criteria
- Female and male patients ≥ 20 years of age (legal age limit in Taiwan) with a confirmed diagnosis of AF (non-valvular). - Treatment with VKA for at least 6 weeks. - Decision to initiate treatment with Rivaroxaban has been made as per investigator’s routine treatment practice. Written informed consent of the patient. - Wilingness and capability to conduct two F2F interviews.
Exclusion Criteria
- Contraindications to the use of Rivaroxaban as outlined in the local product information . - Concomitant treatment with any other anticoagulants. - Participation in another study (clinical intervention/observational) within the 3 months prior to enrollment. - Patients participating in an investigational program with interventions outside of routine clinical practice.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Many Locations Many Locations, Taiwan, China | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
Xarelto Evidence in Real Life of Patients Preference and Satisfaction Study.
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Patient preferences for anticoagulant treatment attributes (utility values obtained in Logit/Probit estimates)The preferred attributes will be assessed by a questionnaire following a discrete choice experimental design.Timeframe: At 3 months
Secondary Outcome
- Change of the Anti-clot treatment scale (ACTS) benefit and burden score from baseline (on VKA) to 3 months (on Xarelto)ACTS = Anti Clot treatment Scale is a questionnaire of 17 items (13 items on burden of treatment and 4 items on the benefits of treatment)Timeframe: At 0 month and at 3 months
- AF symptoms as measured by European Heart Rhythm Association (EHRA) symtoms (both severity and frequency)Timeframe: At 3 months
- Reasons for switch from VKA to XareltoThe reasons are selected by the participant out of a qualitative list of reasons for switch from VKA to Xarelto.Timeframe: At 0 month
Additional Information
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