Evaluating Medication Adherence to Novel Oral Anticoagulants With Anticoagulant Activity Monitoring in Patients With Atrial Fibrillation
1 other identifier
observational
200
1 country
7
Brief Summary
The novel oral anticoagulants such as rivaroxaban, apixaban and dabigatran, specifically target either thrombin or factor Xa/IIa. These new agents are included as an option for prevention of thromboembolic disease or recurrent stroke in patients with non-valvular atrial fibrillation in guidelines. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2018
Typical duration for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2018
CompletedFirst Submitted
Initial submission to the registry
September 10, 2018
CompletedFirst Posted
Study publicly available on registry
September 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedJune 11, 2020
June 1, 2020
2.3 years
September 10, 2018
June 10, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Pharmacodynamic indicators
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.).
at least 1 week after drug administration
Medication adherence
A compliance questionnaire was conducted to collect the compliance of the drug during treatment. 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.
at least 1 week after drug administration
Study Arms (2)
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.
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.
Eligibility Criteria
Patients who take NOACs at Peking University First Hospital
You may qualify if:
- confirmed diagnosis of NOACs indications, such as thromboprophylaxis for non-valvular atrial fibrillation, prevention or treatment of deep vein thrombosis/pulmonary embolism, and thromboprophylaxis after knee/hip replacement.
- Age \>18 years old, unlimited for gender.
- Written or phoned informed consent was obtained from all patients or their families.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cui Yiminlead
Study Sites (7)
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, 100034, 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
Related Publications (1)
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.
PMID: 33224753DERIVED
Biospecimen
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.).
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director of pharmacy，M.D & Ph.D
Study Record Dates
First Submitted
September 10, 2018
First Posted
September 12, 2018
Study Start
September 1, 2018
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
June 11, 2020
Record last verified: 2020-06