The Adherence to Oral Anticoagulant in Chinese Patients With NVAF

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04942873
Collaborator
(none)
500
1
22.7
22.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: adherence

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 Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Study of Compliance and Influencing Factors in Chinese Patients With Nonvalvular Atrial Fibrillation (NVAF) to Oral Anticoagulant
Anticipated Study Start Date :
Jul 20, 2021
Anticipated Primary Completion Date :
Jun 6, 2022
Anticipated Study Completion Date :
Jun 10, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. The long-term compliance of oral anticoagulants in NVAF patients was compared among warfarin group, dabigatran group and rivaroxaban group. [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.

Secondary Outcome Measures

  1. 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]

    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

  2. Through multivariate logistic regression analysis, to clarify the impact of various factors on long-term compliance of patients. [6 months]

    Univariate analysis of significant variables, further by multivariate logistic regression analysis

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chang Cuie Hangzhou Zhejiang China 086

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT04942873
Other Study ID Numbers:
  • 2020-966
First Posted:
Jun 29, 2021
Last Update Posted:
Jun 29, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 29, 2021