The Adherence to Oral Anticoagulant in Chinese Patients With NVAF (NVAF)

June 20, 2021 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 086
        • Chang Cuie
        • Contact:
        • Contact:
        • Principal Investigator:
          • huang yuwen, master

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Through the hospital information system (HIS), the information of patients using warfarin, dabigatran and rivaroxaban during 2016.1-2-2021.1 was retrieved

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: adherence
PDC value and MMAS-8 scale were used to evaluate the compliance of patients with dabigatran, rivaroxaban and wafarin
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.
Other: adherence
PDC value and MMAS-8 scale were used to evaluate the compliance of patients with dabigatran, rivaroxaban and wafarin
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.
Other: adherence
PDC value and MMAS-8 scale were used to evaluate the compliance of patients with dabigatran, rivaroxaban and wafarin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The long-term compliance of oral anticoagulants in NVAF patients was compared among warfarin group, dabigatran group and rivaroxaban group.
Time Frame: 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 6 months
Data 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
6 months
Through multivariate logistic regression analysis, to clarify the impact of various factors on long-term compliance of patients.
Time Frame: 6 months
Univariate analysis of significant variables, further by multivariate logistic regression analysis
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Principal Investigator: huang yuwen, master, The Second Affiliated Hospital of Medical College of Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 20, 2021

Primary Completion (Anticipated)

June 6, 2022

Study Completion (Anticipated)

June 10, 2023

Study Registration Dates

First Submitted

June 10, 2021

First Submitted That Met QC Criteria

June 20, 2021

First Posted (Actual)

June 29, 2021

Study Record Updates

Last Update Posted (Actual)

June 29, 2021

Last Update Submitted That Met QC Criteria

June 20, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-966

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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