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

Not Applicable

Completed

• Conditions: Anticoagulants
• Interventions: Other: prescribing anticoagulant therapy

• Registration Number: NCT05319340
• Lead Sponsor: I.M. Sechenov First Moscow State Medical University

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.

Study Timeline

• Study Start: 2014-01-15
• Status Verified: 2021-03
• Primary Completion: 2021-03-02
• Study Completion: 2021-03-02
• Study First Submitted: 2021-03-03
• Study First Submitted QC: 2022-03-31
• Last Update Submitted: 2022-03-31
• Study First Posted: 2022-04-08
• Last Update Posted: 2022-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
anticoagulants arm	prescribing anticoagulant therapy	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

Primary Outcome Measures

Name	Time	Method
death due to any cause	in six years after the anticoagulant therapy is prescribed	phone survey when patients are invited to the clinic
kidney compliance with the anticoagulant therapy and its safety and trends in the kidney function	Evaluation of GFR, bleeding and thrombotic complications after 2 years	During a visit to the clinic, the patient will be surveyed and tested for the creatinine level
cardiovascular mortality	Evaluation of GFR, bleeding and thrombotic complications and cardiac mortality after 2 years	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.
kidney function trend	Evaluation of GFR, bleeding and thrombotic complications and cardiac mortality after 3 years	phone survey when patients are invited to the clinic for testing the creatinine level and further estimation of the glomerular filtration rate
intensive bleeding	Evaluation of GFR, bleeding and thrombotic complications and cardiac mortality after 6 years	phone survey when patients are invited to the clinic.

Secondary Outcome Measures

Name	Time	Method
frequency of thromboembolic events	in 1-2-3-6 years after the anticoagulant therapy is prescribed	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).