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

June 10, 2020 updated by: Cui Yimin

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
      • Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital
        • Contact:
          • Qian Xiang, Ph.D
      • Fuzhou, China
      • Fuzhou, China
        • Recruiting
        • Fuzhou General Hospital of Nanjing Militray Command
        • Contact:
      • Hefei, China
        • Recruiting
        • Anhui Provincial Hospital#The First Affiliated Hospital Of USTC#
        • Contact:
    • Chongqing
      • Chongqing, Chongqing, China
        • Recruiting
        • The Second Affiliated Hospital of Chongqing Medical University
        • Contact:
          • Na Wang
    • Henan
      • Zhengzhou, Henan, China
        • Recruiting
        • The 7th People's hospital of the zhengzhou
        • Contact:
          • Dongdong Yuan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who take NOACs at Peking University First Hospital

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Other

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.).
at least 1 week after drug administration
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.
at least 1 week after drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cui Yimin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

September 10, 2018

First Submitted That Met QC Criteria

September 10, 2018

First Posted (Actual)

September 12, 2018

Study Record Updates

Last Update Posted (Actual)

June 11, 2020

Last Update Submitted That Met QC Criteria

June 10, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018[136]

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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