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

Anticoagulants Clinical Trial

Official title:

Optimization of Anticoagulant Therapy in Outpatient Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05319340
• Other study ID #: 678657
• Status: Completed
• Phase: N/A
• Start date: January 15, 2014
• Est. completion date: March 2, 2021

Study information

• Verified date: March 2021
• Source: I.M. Sechenov First Moscow State Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Single-institution uncontrolled open-label trial.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: March 2, 2021
• Est. primary completion date: March 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Anticoagulants

Intervention

Other:
• prescribing anticoagulant therapy
Patients who need anticoagulants were consulted by a cardiologist with subsequent recommendations

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
I.M. Sechenov First Moscow State Medical University

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	death due to any cause	phone survey when patients are invited to the clinic	in six years after the anticoagulant therapy is prescribed
Primary	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
Primary	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
Primary	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	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