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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04942873
Other study ID # 2020-966
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 20, 2021
Est. completion date June 10, 2023

Study information

Verified date June 2021
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact chang cuie, master
Phone 15990165032
Email changcuie123@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 500
Est. completion date June 10, 2023
Est. primary completion date June 6, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China Chang Cuie Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. 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
Secondary Through multivariate logistic regression analysis, to clarify the impact of various factors on long-term compliance of patients. Univariate analysis of significant variables, further by multivariate logistic regression analysis 6 months
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