AnticoagulantsNCT03666962
Evaluating Medication Adherence to Novel Oral Anticoagulants With Anticoagulant Activity Monitoring in Patients With Atrial Fibrillation
An observational study of Anticoagulants and Compliance, Medication, run by Cui Yimin at 7 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anticoagulants, Compliance, Medication
- How many people
- 200 participants
- Where
- 7 sitesChina
- Study dates
- 1 Sep 2018to 31 Dec 2020
- 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: Patients who take NOACs at Peking University First Hospital
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Peking University First Hospital
Beijing, 100034
Qian Xiang, Ph.D
- Recruiting
Beijing Hospital
Beijing
Yatong Zhang, zyt2002888@qq.com
- Recruiting
The Second Affiliated Hospital Of Chongqing Medical University
Chongqing, Chongqing Municipality
Na Wang
- Recruiting
Fujian Medical University Union Hospital
Fuzhou
Jinhua Zhang, pollyzhang2006@126.com
- Recruiting
Fuzhou General Hospital of Nanjing Militray Command
Fuzhou
Taotao Hu, 412456139@qq.com
- Recruiting
Anhui Provincial Hospital#The First Affiliated Hospital Of USTC#
Hefei
Zhaoyi Yang, young2382@163.com
- Recruiting
The 7th People's hospital of the zhengzhou
Zhengzhou, Henan
Dongdong Yuan
About this study
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.
Read the 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.
- Conditions
- Anticoagulants, Compliance, Medication
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.).
Measured: 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.
Measured: at least 1 week after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start1 Sep 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnticoagulantsStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cui Yimin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cui Yimin, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03666962
- Sponsor's protocol ID
- 2018[136]
- Status last verified
- Jun 2020
- First submitted
- 10 Sep 2018
- Last updated
- 11 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33224753
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Medication Adherence to Novel Oral Anticoagulants With Anticoagulant Activity Monitoring in Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03666962
- Acronym / sponsor ID
- 2018[136]
- Conditions
- Anticoagulants, Compliance, Medication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cui YiminUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 12 Sep 2018 (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.
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.
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
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who take NOACs at Peking University First Hospital
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.).
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Derived from this study: PubMed 33224753Liu 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.
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anticoagulants and Compliance, Medication, run by Cui Yimin at 7 sites 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 3 inclusion and 0 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 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 Qian Xiang, Ph.D (+86 010 66110802, xiangqz@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacodynamic indicators (time frame: at least 1 week after drug administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03666962, which also lists 1 linked publication.
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 11 Jun 2020.