I.M. Sechenov First Moscow State Medical University (Sechenov University)

Study Overview
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Brief Summary
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Single-institution uncontrolled open-label trial.

Detailed Description
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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.

Official Title
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Optimization of Anticoagulant Therapy in Outpatient Practice

Conditions
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Anticoagulants

Intervention / Treatment
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* Other: prescribing anticoagulant therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: the age above 18 indications for the anticoagulant therapy informed consent for inclusion into trials Exclusion Criteria: denial to proceed in the trial Non-inclusion criteria: pregnancy and lactation Intracerebral hemorrhage within three preceding months severe mental disorders* which could possibly affect the anticoagulant therapy dosage schedule anemia and a decrease in Hb by ˂100 GM/DL* active gastroduodenal ulcer active bleeding during the preceding month other intensive bleeding instances as per the TIMI Score within three weeks before the inclusion severe hepatic impairment for over 10 points under the Child-Pugh Score oncology disease with the life expectancy less than one year

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: anticoagulants arm<br>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 | Other: prescribing anticoagulant therapy<br>* Patients who need anticoagulants were consulted by a cardiologist with subsequent recommendations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rivaroxaban Dabigatran Apixaban