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

I.M. Sechenov First Moscow State Medical University

Status: Completed

Conditions: Anticoagulants

Treatments: Other: prescribing anticoagulant therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05319340

678657

Details and patient eligibility

About

Single-institution uncontrolled open-label trial.

Full 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.

Enrollment: 1,000 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,000 participants in 1 patient group

anticoagulants arm

Other group

Description:

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

Treatment:

Other: prescribing anticoagulant therapy