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

NCT05319340 | Completed DMC

• 1 other identifier: 678657
• Study Type: interventional
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

Single-institution uncontrolled open-label trial.

Conditions

Anticoagulants

Keywords

Rivaroxaban Dabigatran Apixaban

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• frequency of thromboembolic events

  in 1-2-3-6 years after the anticoagulant therapy is prescribed

Other Outcomes (1)

• minor bleeding

  in 1-2-3-6 years after the anticoagulant therapy is prescribed

Study Arms (1)

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

Other: prescribing anticoagulant therapy

Interventions

prescribing anticoagulant therapy OTHER

Patients who need anticoagulants were consulted by a cardiologist with subsequent recommendations

anticoagulants arm

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• the age above 18
• indications for the anticoagulant therapy

You may not qualify if:

• denial to proceed in the trial
• 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
• severe hepatic impairment for over 10 points under the Child-Pugh Score
• oncology disease with the life expectancy less than one year

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Related Publications (1)

• 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.

  PMID: 32345197 BACKGROUND

Study Officials

• Zukhra Salpagarova

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: April 8, 2022
• Study Start: January 15, 2014
• Primary Completion: March 2, 2021
• Study Completion: March 2, 2021
• Last Updated: April 8, 2022

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share