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Single-institution uncontrolled open-label trial.
The single-institution uncontrolled open-label trial is to optimize the anticoagulant therapy in the out-patient practice.
The study embraces patients who are advised to take the anticoagulant therapy for some reasons. The study has two phases - a retrospective part and a concurrent part. At the first phase, researchers analyze the compliance with the anticoagulant therapy in the real clinical practice. At the concurrent phase, researchers conduct a single-institution uncontrolled open-label trial to evaluate the effectiveness, safety of the anticoagulant therapy and compliance with it at the antithrombotic therapy control ward, and estimate the glomerular filtration rate in patients taking the anticoagulant therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| anticoagulants arm | Other | The study embraces patients who are advised to take the anticoagulant therapy (as per the European Society of Cardiology Guidelines). The study evaluates the compliance with the anticoagulant therapy, safety and effectiveness, mortality |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prescribing anticoagulant therapy | Other | Patients who need anticoagulants were consulted by a cardiologist with subsequent recommendations |
|
| Measure | Description | Time Frame |
|---|---|---|
| kidney compliance with the anticoagulant therapy and its safety and trends in the kidney function | During a visit to the clinic, the patient will be surveyed and tested for the creatinine level | Evaluation of GFR, bleeding and thrombotic complications after 2 years |
| death due to any cause | phone survey when patients are invited to the clinic | in six years after the anticoagulant therapy is prescribed |
| cardiovascular mortality | Phone survey when patients are invited to the clinic. The term cardiovascular mortality means a set of fatal heart attacks, fatal strokes, sudden death, fatal thromboembolism. | Evaluation of GFR, bleeding and thrombotic complications and cardiac mortality after 2 years |
| kidney function trend | phone survey when patients are invited to the clinic for testing the creatinine level and further estimation of the glomerular filtration rate | Evaluation of GFR, bleeding and thrombotic complications and cardiac mortality after 3 years |
| intensive bleeding | phone survey when patients are invited to the clinic. | Evaluation of GFR, bleeding and thrombotic complications and cardiac mortality after 6 years |
| Measure | Description | Time Frame |
|---|---|---|
| frequency of thromboembolic events | patients will be surveyed upon their visit to the clinic. Thromboembolic events shall mean non-fatal embolic strokes, systemic embolism, acute coronary syndrome (to be corroborated with documents). | in 1-2-3-6 years after the anticoagulant therapy is prescribed |
| Measure | Description | Time Frame |
|---|---|---|
| minor bleeding | Minor bleeding shall mean any visually observed bleeding, including that discovered with various imaging methods, which cause a decrease in HB by less than 30 GM/DL or Ht by less than 9%. | in 1-2-3-6 years after the anticoagulant therapy is prescribed |
Inclusion Criteria:
Exclusion Criteria:
Non-inclusion criteria:
pregnancy and lactation
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| Name | Affiliation | Role |
|---|---|---|
| Zukhra Salpagarova | I.M. Sechenov First Moscow State Medical University (Sechenov University) | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32345197 | Background | Chashkina MI, Kozlovskaya NL, Andreev DA, Ananicheva NA, Bykova AA, Salpagarova ZK, Syrkin AL. [Prevalence of Advanced Chronic Kidney Disease in Patients with Nonvalvular Atrial Fibrillation Hospitalized in Cardiology Departments]. Kardiologiia. 2020 Mar 5;60(2):41-46. doi: 10.18087/cardio.2020.2.n823. Russian. |
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ethics committee requirement
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