The Adherence to Oral Anticoagulant in Chinese Patients With NVAF
NVAF
Study of Compliance and Influencing Factors in Chinese Patients With Nonvalvular Atrial Fibrillation (NVAF) to Oral Anticoagulant
1 other identifier
observational
500
1 country
1
Brief Summary
Investigate the compliance of oral anticoagulants in Chinese NVAF patients and find out the causes, so as to provide basis for formulating effective measures to improve the compliance of oral anticoagulants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2021
CompletedFirst Posted
Study publicly available on registry
June 29, 2021
CompletedStudy Start
First participant enrolled
July 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 6, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2023
CompletedJune 29, 2021
June 1, 2021
11 months
June 10, 2021
June 20, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The long-term compliance of oral anticoagulants in NVAF patients was compared among warfarin group, dabigatran group and rivaroxaban group.
In this study, the eight item Morisky medication adherence scale (MMAS-8) was used to compare the long-term compliance of patients with warfarin, dabigatran axetil and rivaroxaban. The proportion of days covered (PDC) was used to compare the long-term compliance of patients with dabigatran and rivaroxaban.
6 months
Secondary Outcomes (2)
Explore the influence of different factors on patients' compliance, and to find out the factors influencing patients' long-term compliance, so as to provide basis for formulating strategies to improve patients' long-term compliance.
6 months
Through multivariate logistic regression analysis, to clarify the impact of various factors on long-term compliance of patients.
6 months
Study Arms (3)
dabigatran group
NVAF patients who taking dabigatran capsule 110mg，bid during 2016.2-2021.1，the duration of continuous medication was more than 3 months.PDC value and MMAS-8 scale were used to evaluate the compliance of patients with dabigatran.
Rivaroxaban group
NVAF patients who taking rivaroxaban tablet 15mg，bid during 2016.2-2021.1，the duration of continuous medication was more than 3 months.PDC value and mmas-8 scale were used to evaluate the compliance of patients with dabigatran. PDC value and mmas-8 scale were used to evaluate the compliance of patients with rivaroxaban.
wafarin group
NVAF patients who taking wafarin tablet during 2016.2-2021.1，the duration of continuous medication was more than 3 months， the dosage is adjusted according to INR. MMAS-8 scale was used to evaluate the compliance of patients with rivaroxaban.evaluate the compliance of patients with wafarin.
Interventions
PDC value and MMAS-8 scale were used to evaluate the compliance of patients with dabigatran, rivaroxaban and wafarin
Eligibility Criteria
Through the hospital information system (HIS), the information of patients using warfarin, dabigatran and rivaroxaban during 2016.1-2-2021.1 was retrieved
You may qualify if:
- NVAF; CHA2DS2-VASc≥2（femal≥3）; After starting the medication, the duration of continuous medication was more than 3 months
You may not qualify if:
- The patients had the records of anticoagulants in other hospitals; Patients lost to follow-up; Patients who do not need long-term anticoagulants after successful radiofrequency ablation or left atrial appendage occlusion. The follow-up time was 3 years or the following conditions occurred: the patient's condition changed and no longer used oral anticoagulants or died, the follow-up was stopped.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chang Cuie
Hangzhou, Zhejiang, 086, China
Study Officials
- PRINCIPAL INVESTIGATOR
huang yuwen, master
The Second Affiliated Hospital of Medical College of Zhejiang University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2021
First Posted
June 29, 2021
Study Start
July 20, 2021
Primary Completion
June 6, 2022
Study Completion
June 10, 2023
Last Updated
June 29, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share