Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-01-01 @ 6:56 AM
Study NCT ID:
NCT02611635
Status:
COMPLETED
Last Update Posted:
2018-02-07
First Post:
2015-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atrial Fibrillation Patient Preference Study
Sponsor:
Bayer
Organization:
Study Overview
Official Title:
AF Patient Preferences Towards NOAC Versus VKA Treatment: a Patient Preference Study.
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRiSMA-AF
Brief Summary:
The main research question of this patient survey is to assess AF patients' preferences associated with different attributes which describe the different available anticoagulation treatment options (VKA or NOACs and, in case of NOACs, Apixaban, Dabigatran or Rivaroxaban).
VKA (Waran®) will be compared to Rivaroxaban.
VKA (Waran®) will be compared to Rivaroxaban.
Detailed Description:
The objective of this study is to investigate the following research questions in a cross-sectional survey of Swedish 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 Swedish 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 Swedish 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?
* 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 Swedish 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 Swedish 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?
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: