Anticoagulants Clinical Trial
Official title:
Evaluating Medication Adherence to Novel Oral Anticoagulants With Anticoagulant Activity Monitoring in Patients With Atrial Fibrillation
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT02128841 -
Comparison of Antithrombotic Treatments After Aortic Valve Replacement. Rivaroxaban: A New Antithrombotic Treatment for Patients With Mechanical Prosthetic Aortic Heart Valve.
|
Phase 2 | |
| Recruiting |
NCT03670446 -
Pharmacists' Intervention in Patients Using Novel Oral Anticoagulants：A Study on Behavioral Patterns
|
N/A | |
| Recruiting |
NCT04796714 -
AntiPlatelet theraPy stratEgy followiNg Left Atrial appenDAGe closurE
|
Phase 4 | |
| Completed |
NCT01033279 -
Quality of Life and Efficacy Evaluation of Patient Self-monitoring Their Oral Anticoagulation Therapy
|
N/A | |
| Completed |
NCT00287313 -
Daily Vitamin K in Patients on Warfarin With Unstable INRs
|
N/A | |
| Completed |
NCT00222638 -
Influenza Vaccination and Oral Anticoagulant Therapy
|
Phase 4 | |
| Active, not recruiting |
NCT06203795 -
Dialysis Performance of the FX CorAL Membrane
|
N/A | |
| Completed |
NCT03864900 -
Efficacy of a Health Belief Model Based Intervention for Anticoagulation Adherence
|
N/A | |
| Active, not recruiting |
NCT06401863 -
Shared Decision for Drug Interactions in Oral Anticoagulation
|
N/A | |
| Not yet recruiting |
NCT04977076 -
Comparison Between Direct Oral Anticoagulation (DOAC) Interruption and DOAC Continuation in Patients Undergoing Elective Invasive Coronary Angiography or Percutaneous Coronary Intervention
|
N/A | |
| Recruiting |
NCT04861103 -
Anticoagulation Profile in Pregnant Women Treated With Three Times a Day of Low Molecular Weight Heparin (LMWH)
|
Phase 4 | |
| Completed |
NCT01653405 -
Improving Anticoagulation Control in VISN 1
|
N/A | |
| Not yet recruiting |
NCT05820854 -
Self-care and Self-efficacy Scale in Oral Anticoagulation Therapy
|
||
| Completed |
NCT04681482 -
Effectiveness And Safety Of Oral Anticoagulants Among Obese Patients With Non-Valvular A-Fib In VA Patients With Medicare
|
||
| Not yet recruiting |
NCT06137794 -
Application of "I-Anticoagulation"in Patients With Atrial Fibrillation
|
N/A | |
| Completed |
NCT02103101 -
Influence of ABCB1 Polymorphisms on Plasma Concentrations of New Oral Anticoagulants in Case of Serious Adverse Events
|
N/A | |
| Active, not recruiting |
NCT05065502 -
MIDAS Cluster Randomized Controlled Trial of Implementation Strategies to Optimize Use of Medications in VA Clinical Settings
|
N/A | |
| Recruiting |
NCT03965208 -
Safety and Efficacy of Bivalirudin Versus Heparin for Systemic Anticoagulation in Extracorporeal Membrane Oxygenation
|
Phase 4 | |
| Completed |
NCT03318393 -
Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric ECMO
|
Phase 4 | |
| Recruiting |
NCT03288441 -
Management and Outcomes of Anti-thrombotic Medication Use in Thrombocytopenia
|