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Evaluating Medication Adherence to Novel Oral Anticoagulants With Anticoagulant Activity Monitoring in Patients With Atrial Fibrillation

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ClinicalTrials.gov Identifier: NCT03666962
Recruitment Status : Recruiting
First Posted : September 12, 2018
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Cui Yimin, Peking University First Hospital

Study Description
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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.


Condition or disease
Anticoagulants Compliance, Medication

Detailed Description:

Patients with new oral anticoagulants will be included in the study. After the signing of the informed consent, blood samples were collected to detect the anti Xa factor activity after taking the drugs. Meanwhile, the medication compliance of the patients during the treatment was also collected.

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: Evaluating Medication Adherence to Novel Oral Anticoagulants With Anticoagulant Activity Monitoring in Patients With Atrial Fibrillation
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. Pharmacodynamic indicators [ Time Frame: at least 1 week after drug administration ]
    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.).

  2. Medication adherence [ Time Frame: at least 1 week after drug administration ]
    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.


Biospecimen Retention:   Samples Without DNA
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.).

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who take NOACs at Peking University First Hospital
Criteria

Inclusion Criteria:

  1. 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.
  2. Age >18 years old, unlimited for gender.
  3. Written or phoned informed consent was obtained from all patients or their families.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03666962


Contacts
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Contact: Qian Xiang, Ph.D +86 010 66110802 xiangqz@126.com

Locations
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China, Chongqing
The Second Affiliated Hospital Of Chongqing Medical University Recruiting
Chongqing, Chongqing, China
Contact: Na Wang         
China, Henan
The 7th People's hospital of the zhengzhou Recruiting
Zhengzhou, Henan, China
Contact: Dongdong Yuan         
China
Peking University First Hospital Recruiting
Beijing, China, 100034
Contact: Qian Xiang, Ph.D         
Beijing Hospital Recruiting
Beijing, China
Contact: Yatong Zhang       zyt2002888@qq.com   
Fujian Medical University Union Hospital Recruiting
Fuzhou, China
Contact: Jinhua Zhang       pollyzhang2006@126.com   
Fuzhou General Hospital of Nanjing Militray Command Recruiting
Fuzhou, China
Contact: Taotao Hu       412456139@qq.com   
Anhui Provincial Hospital#The First Affiliated Hospital Of USTC# Recruiting
Hefei, China
Contact: Zhaoyi Yang       young2382@163.com   
Sponsors and Collaborators
Cui Yimin
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Cui Yimin, Director of pharmacy，M.D & Ph.D, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT03666962    
Other Study ID Numbers: 2018[136]
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes