Clinical trial NCT05319340: I.M. Sechenov First Moscow State Medical University (Sechenov University)
Official title: Optimization of Anticoagulant Therapy in Outpatient Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anticoagulants
Keywords: Rivaroxaban Dabigatran Apixaban
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Single-institution uncontrolled open-label trial.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: kidney compliance with the anticoagulant therapy and its safety and trends in the kidney function
timeFrame: Evaluation of GFR, bleeding and thrombotic complications after 2 years
measure: death due to any cause
timeFrame: in six years after the anticoagulant therapy is prescribed
measure: cardiovascular mortality
timeFrame: Evaluation of GFR, bleeding and thrombotic complications and cardiac mortality after 2 years
measure: kidney function trend
timeFrame: Evaluation of GFR, bleeding and thrombotic complications and cardiac mortality after 3 years
measure: intensive bleeding
timeFrame: Evaluation of GFR, bleeding and thrombotic complications and cardiac mortality after 6 years
Secondary outcomes:
measure: frequency of thromboembolic events
timeFrame: in 1-2-3-6 years after the anticoagulant therapy is prescribed
Other outcomes:
measure: minor bleeding
timeFrame: in 1-2-3-6 years after the anticoagulant therapy is prescribed
Locations:
Study officials:
affiliation: I.M. Sechenov First Moscow State Medical University (Sechenov University)
name: Zukhra Salpagarova
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.