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

N/ACompletedNCT05319340

I.M. Sechenov First Moscow State Medical University1,000 enrolled

Overview

Single-institution uncontrolled open-label trial.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

1,000

Conditions

Anticoagulants

Interventions

prescribing anticoagulant therapyOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

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

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

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

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

Data from ClinicalTrials.gov

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