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出境医 / 临床实验 / The Adherence to Oral Anticoagulant in Chinese Patients With NVAF (NVAF)
The Adherence to Oral Anticoagulant in Chinese Patients With NVAF (NVAF)
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 |
|---|---|
| Nonvalvular Atrial Fibrillation | Other: adherence |
Detailed Description:
- 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.
- 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 |
| Estimated 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 |
| Estimated Study Start Date : | July 20, 2021 |
| Estimated Primary Completion Date : | June 6, 2022 |
| Estimated Study Completion Date : | June 10, 2023 |
Arms 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
|
Outcome Measures
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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
- 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
Eligibility Criteria
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| 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
Criteria
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
Contacts
| Contact: chang cuie, master | 15990165032 | changcuie123@163.com | |
| Contact: zhang xiaoyu, master | 18858160685 | 474430517@qq.com |
Locations
| China, Zhejiang | |
| Chang Cuie | |
| Hangzhou, Zhejiang, China, 086 | |
| Contact: chang cuie, master 086-15990165032 changcuie123@163.com | |
| Contact: zhang xiaoyu, master 086-18858160685 474430517@qq.com | |
| Principal Investigator: huang yuwen, master | |
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 |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | June 10, 2021 | ||||||||
| First Posted Date | June 29, 2021 | ||||||||
| Last Update Posted Date | June 29, 2021 | ||||||||
| Estimated Study Start Date | July 20, 2021 | ||||||||
| Estimated Primary Completion Date | June 6, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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.
|
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | The Adherence to Oral Anticoagulant in Chinese Patients With NVAF | ||||||||
| Official Title | Study of Compliance and Influencing Factors in Chinese Patients With Nonvalvular Atrial Fibrillation (NVAF) to Oral Anticoagulant | ||||||||
| 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 |
|
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| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| 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 | ||||||||
| Condition | Nonvalvular Atrial Fibrillation | ||||||||
| Intervention | Other: adherence
PDC value and MMAS-8 scale were used to evaluate the compliance of patients with dabigatran, rivaroxaban and wafarin
|
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| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Not yet recruiting | ||||||||
| Estimated Enrollment |
500 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | June 10, 2023 | ||||||||
| Estimated Primary Completion Date | June 6, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
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. |
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| Sex/Gender |
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| Ages | Child, Adult, Older Adult | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | China | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04942873 | ||||||||
| Other Study ID Numbers | 2020-966 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||||||||
| Study Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||||||||
| Verification Date | June 2021 | ||||||||