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CompletedNCT05319340Updated Apr 8, 2022

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

An interventional study of prescribing anticoagulant therapy in Anticoagulants, sponsored by I.M. Sechenov First Moscow State Medical University. Completed. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2022-04-08.

Sponsored by I.M. Sechenov First Moscow State Medical University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
1,000
Allocation
Not applicable
Ages
18 Years to 120 Years
Sex
All
01

Study summary

Single-institution uncontrolled open-label trial.

Read the 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.

02

Conditions studied

  • Anticoagulants

Keywords

  • Rivaroxaban Dabigatran Apixaban
03

In context

Lead sponsor

I.M. Sechenov First Moscow State Medical University is the lead sponsor of 133 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • the age above 18
  • indications for the anticoagulant therapy
  • informed consent for inclusion into trials

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1,000 participants (actual)

Study arms

  • 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

Interventions

  • Otherprescribing anticoagulant therapy

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Evaluation of GFR, bleeding and thrombotic complications after 2 years

  2. death due to any cause

    phone survey when patients are invited to the clinic

    Time frame: in six years after the anticoagulant therapy is prescribed

  3. 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.

    Time frame: Evaluation of GFR, bleeding and thrombotic complications and cardiac mortality after 2 years

  4. 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

    Time frame: Evaluation of GFR, bleeding and thrombotic complications and cardiac mortality after 3 years

  5. intensive bleeding

    phone survey when patients are invited to the clinic.

    Time frame: Evaluation of GFR, bleeding and thrombotic complications and cardiac mortality after 6 years

Secondary outcomes

  1. 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).

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

Other outcomes

  1. 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%.

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

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Study locations

No study locations are listed for this record.

08

References and documents

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. PubMed 32345197 ↗

Individual participant data

Plan to share: No — ethics committee requirement

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05319340
Lead sponsor
I.M. Sechenov First Moscow State Medical University
Responsible party
Sponsor
First posted
Apr 8, 2022
Start date
Jan 15, 2014
Primary completion
Mar 2, 2021
Completion
Mar 2, 2021
Last update
Apr 8, 2022

Study contacts

Zukhra Salpagarova
principal investigator · I.M. Sechenov First Moscow State Medical University (Sechenov University)

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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