Evaluating Medication Adherence to Novel Oral Anticoagulants With Anticoagulant Activity Monitoring in Patients With Atrial Fibrillation
NCT ID: NCT03666962
Last Updated: 2020-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
200 participants
OBSERVATIONAL
2018-09-01
2020-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Although the benefits and risks of anticoagulation and antiplatelet therapy have been fully assessed, and reasonable anticoagulation and antiplatelet therapies have been formulated, the therapeutic effect still largely depends on the quality control during the treatment. Many patients discontinue anticoagulant therapy after discharge or after a period of treatment, and the risk of thrombosis increases. Because non-vitamin K antagonist oral anticoagulants (NOACs) does not need routine monitoring, patients tend to ignore the regular medication, thus affecting drug compliance. Because of the short half-life of NOACs, if patients do not take it regularly, not only can not achieve the effectiveness of anticoagulation, but also reduce the safety of medication. More and more researchers have realized that medication adherence plays a key role in medical management. In order to improve the efficacy and safety of NOACs and the compliance of patients with NOACs, the guidelines emphasize that supplementary measures can be taken, such as pharmacists participating in the network pharmacy database, attaching importance to the medication education of patients and their families, formulating a strict follow-up plan and professional outpatient follow-up.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Real-World Comparison of Safety and Effectiveness of Novel Oral Anti-Coagulant (NOAC) Naïve and Warfarin Naïve Non-Valvular Atrial Fibrillation (NVAF) Patients With Medicare Advantage Coverage
NCT03189069
Oral Anticoagulant Discontinuation, Adherence Patterns, Hospitalizations and Costs in Non-Valvular Atrial Fibrillation (NVAF) Patients
NCT02792335
Comparative Study of Oral Anticoagulation in Left Ventricular Thrombi
NCT03926780
Specific Anti Factor Xa Activity Dosage to Enhance Detection of Nonadherence in Atrial Fibrillation Patients
NCT02925247
Impact of Biomarkers on Pharmacokinetics and Pharmacodynamics of Direct Oral Anticoagulants
NCT03161496
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Dedicated tests based on anti-Xa activity for rivaroxaban and apixaban and anti-IIa activity for dabigatran concentration was conducted. Blood samples are divided into peak concentration and valley concentration. Peak concentration (Cmax) refers to the highest serum concentration after administration for at least one week in the study. Valley concentration (Cmin), the lowest concentration during administration, is usually obtained from the lowest concentration between the initial time of administration and the next time the drug is administered at a steady state (continuous medication for more than 1 weeks.).
A compliance questionnaire was conducted to collect the compliance of the drug during treatment. The Morisky, Green, and Levine Adherence Scale (MGLS) was used to evaluate the medication adherence of non-vitamin K antagonist oral anticoagulants (NOACs) patients.
Based on the results of data analysis, the correlation between anti Xa/IIa activity test results and medication compliance was analyzed, making the anti Xa/IIa activity concentration a simple measure to predict the compliance of patients.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
OTHER
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
case group
According to the scores of MGLS, compliance was divided into three groups: A score of 0 indicated high compliance; a score of 1 or 2 illustrated intermediate compliance; and a score of 3 or 4 indicated low compliance.
No interventions assigned to this group
control group
According to the scores of MGLS, compliance was divided into three groups: A score of 0 indicated high compliance; a score of 1 or 2 illustrated intermediate compliance; and a score of 3 or 4 indicated low compliance.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Age \>18 years old, unlimited for gender.
3. Written or phoned informed consent was obtained from all patients or their families.
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cui Yimin
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Cui Yimin
Director of pharmacy，M.D & Ph.D
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Second Affiliated Hospital Of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The 7th People's hospital of the zhengzhou
Zhengzhou, Henan, China
Peking University First Hospital
Beijing, , China
Beijing Hospital
Beijing, , China
Fujian Medical University Union Hospital
Fuzhou, , China
Fuzhou General Hospital of Nanjing Militray Command
Fuzhou, , China
Anhui Provincial Hospital#The First Affiliated Hospital Of USTC#
Hefei, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Na Wang
Role: primary
Dongdong Yuan
Role: primary
Qian Xiang, Ph.D
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Liu Z, Xie Q, Xiang Q, Zhang H, Mu G, Zhao Z, Hu T, Wu T, Wang N, Zhang J, Qian Y, Zhou S, Wang Z, Jiang J, Zhang Y, Song H, Cui Y. Anti-FXa-IIa activity test in Asian and its potential role for drug adherence evaluation in patients with direct oral anticoagulants: a nationwide multi-center synchronization study. Cardiovasc Diagn Ther. 2020 Oct;10(5):1293-1302. doi: 10.21037/cdt-20-564.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2018[136]
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.