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OpenTrials
Completed

NCT Number: NCT05319340

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

Single-institution uncontrolled open-label trial.

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Key information

Conditions

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

prescribing anticoagulant therapy

Other

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

Primary outcomes

  1. kidney compliance with the anticoagulant therapy and its safety and trends in the kidney function

    Time frame: 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

  2. death due to any cause

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

    phone survey when patients are invited to the clinic

  3. cardiovascular mortality

    Time frame: 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.

  4. kidney function trend

    Time frame: 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

  5. intensive bleeding

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

    phone survey when patients are invited to the clinic.

Secondary outcomes

  1. frequency of thromboembolic events

    Time frame: 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).

Other outcomes

  1. minor bleeding

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

    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%.

Sponsors and collaborators

Lead sponsor

I.M. Sechenov First Moscow State Medical University

Other

Registry information

Official study title

Optimization of Anticoagulant Therapy in Outpatient Practice

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Apr 8, 2022
Registry last updated
Apr 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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