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The Adherence to Oral Anticoagulant in Chinese Patients With NVAF

Study of Compliance and Influencing Factors in Chinese Patients With Nonvalvular Atrial Fibrillation (NVAF) to Oral Anticoagulant

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04942873
Acronym
NVAF
Enrollment
500
Registered
2021-06-29
Start date
2021-07-20
Completion date
2023-06-10
Last updated
2021-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nonvalvular Atrial Fibrillation

Keywords

adherence, new oral anticoagulants

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.

Detailed description

1. The general information about these patients was recorded such as gender, age, smoking history, drinking history, heart failure, hypertension, diabetes, coronary heart disease, stroke history, TIA history, peripheral vascular disease, etc. CHA2DS2-VASc score and HAS-BLED score were recorded. 2. Medication information and follow-up information was collected.For the patients included in the study, the medication records of oral anticoagulants (outpatient, emergency, hospitalization), adverse reactions, anticoagulant use history, drug withdrawal or dressing change, disease changes, etc. within three years were recorded by referring to the patient's medical records.

Interventions

OTHERadherence

PDC value and MMAS-8 scale were used to evaluate the compliance of patients with dabigatran, rivaroxaban and wafarin

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

NVAF; CHA2DS2-VASc≥2(femal≥3); After starting the medication, the duration of continuous medication was more than 3 months

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
The long-term compliance of oral anticoagulants in NVAF patients was compared among warfarin group, dabigatran group and rivaroxaban group.6 monthsIn 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.

Secondary

MeasureTime frameDescription
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 monthsData of all influencing factors included in CHA2DS2-VASc score scale, such as age hypertension,heart failure, diabetes, women and vascular diseases, as well as region, medical insurance category, education level, anticoagulant use history and HAS-BLED score
Through multivariate logistic regression analysis, to clarify the impact of various factors on long-term compliance of patients.6 monthsUnivariate analysis of significant variables, further by multivariate logistic regression analysis

Countries

China

Contacts

Primary Contactchang cuie, master
changcuie123@163.com15990165032
Backup Contactzhang xiaoyu, master
474430517@qq.com18858160685

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026