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

Optimization of Anticoagulant Therapy in Outpatient Practice

Single-institution uncontrolled open-label trial.

Study Overview

• Status: Completed
• Conditions: Anticoagulants
• Intervention / Treatment: Other: prescribing anticoagulant therapy

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 Type: Interventional
• Enrollment (Actual): 1000
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: anticoagulants arm; 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; Patients who need anticoagulants were consulted by a cardiologist with subsequent recommendations

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: I.M. Sechenov First Moscow State Medical University
• Investigators: Principal Investigator: Zukhra Salpagarova, I.M. Sechenov First Moscow State Medical University (Sechenov University)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 15, 2014
• Primary Completion (Actual): March 2, 2021
• Study Completion (Actual): March 2, 2021

Study Registration Dates

• First Submitted: March 3, 2021
• First Submitted That Met QC Criteria: March 31, 2022
• First Posted (Actual): April 8, 2022

Study Record Updates

• Last Update Posted (Actual): April 8, 2022
• Last Update Submitted That Met QC Criteria: March 31, 2022
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Rivaroxaban Dabigatran Apixaban
• Additional Relevant MeSH Terms: Anticoagulants
• Other Study ID Numbers: 678657

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: ethics committee requirement

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No