Nonvalvular Atrial FibrillationNVAFNCT04942873
The Adherence to Oral Anticoagulant in Chinese Patients With NVAF
An observational study of Nonvalvular Atrial Fibrillation, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nonvalvular Atrial Fibrillation
- What is being tested?
- adherence
- Type of treatment
- Pill or oral medicine
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2021to 10 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- NVAF; CHA2DS2-VASc≥2（femal≥3）; After starting the medication, the duration of continuous medication was more than 3 months
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Chang Cuie
Hangzhou, Zhejiang, 086
chang cuie, master, 086-15990165032, changcuie123@163.com
zhang xiaoyu, master, 086-18858160685, 474430517@qq.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Nonvalvular Atrial Fibrillation
- Being tested
- adherence
- Keywords
- adherence, new oral anticoagulants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adherenceOther
PDC value and MMAS-8 scale were used to evaluate the compliance of patients with dabigatran, rivaroxaban and wafarin
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: adherence | |
| 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. Receives: Other: adherence | |
| 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. Receives: Other: adherence |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (2)
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
Measured: 6 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start20 Jul 2021 (estimated)
- Primary completion6 Jun 2022 (estimated)
- Study completion10 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonvalvular Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- huang yuwen, master, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04942873
- Sponsor's protocol ID
- 2020-966
- Acronym
- NVAF
- Status last verified
- Jun 2021
- First submitted
- 10 Jun 2021
- Last updated
- 29 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Compliance and Influencing Factors in Chinese Patients With Nonvalvular Atrial Fibrillation (NVAF) to Oral Anticoagulant
- ClinicalTrials.gov ID
- NCT04942873
- Acronym / sponsor ID
- NVAF / 2020-966
- Conditions
- Nonvalvular Atrial Fibrillation
- Keywords
- adherence, new oral anticoagulants
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 20 Jul 2021 (estimated)
- Primary completion
- 6 Jun 2022 (estimated)
- Study completion
- 10 Jun 2023 (estimated)
- First posted
- 29 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| dabigatran group | – | Other: adherenceNVAF 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. |
| Rivaroxaban group | – | Other: adherenceNVAF 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. |
| wafarin group | – | Other: adherenceNVAF 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- NVAF; CHA2DS2-VASc≥2（femal≥3）; After starting the medication, the duration of continuous medication was more than 3 months
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adherencePDC value and MMAS-8 scale were used to evaluate the compliance of patients with dabigatran, rivaroxaban and wafarin | Other | Rivaroxaban group, dabigatran group, wafarin group |
Primary outcome
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.
2 secondary outcomes
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
Through multivariate logistic regression analysis, to clarify the impact of various factors on long-term compliance of patients.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
- Individual participant dataSharing planned: No
Related trials for Nonvalvular Atrial Fibrillation
RecruitingObservational study
Safety and Effectiveness of Short-Term Single AntiPlatelet Therapy After Left Atrial Appendage Closure With the LAmbre Device in Patients With Nonvalvular Atrial Fibrillation: A Multinational Real-world Registry
Atrial Fibrillation
Recruiting
TEE-Guided Versus CCTA-Guided Preprocedural Imaging for Left Atrial Appendage Closure
Nonvalvular Atrial Fibrillation
RecruitingObservational study
Apixaban Safety and Therapy Adherence in Patients With Atrial Fibrillation
Nonvalvular Atrial Fibrillation
RecruitingPhase 4
Non-antithrombotic Versus. Single Antiplatelet Therapy Following Left Atrial Appendage Closure
Nonvalvular Atrial Fibrillation, Aspirin
Not yet recruiting
The Incidence of New-brain Lesions on Brain MRI and Safety Between Edoxaban and Apixaban in Patients with Stroke and Nonvalvular Atrial Fibrillation
Stroke, Atrial Fibrillation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
huang yuwen, master principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nonvalvular Atrial Fibrillation, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact chang cuie, master (15990165032, changcuie123@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The long-term compliance of oral anticoagulants in NVAF patients was compared among warfarin group, dabigatran group and rivaroxaban group. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2021.