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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-15

Study Completion Date

2021-03-02

Brief Summary

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Single-institution uncontrolled open-label trial.

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Detailed Description

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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.

Conditions

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Anticoagulants

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

prescribing anticoagulant therapy

Intervention Type OTHER

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

Interventions

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prescribing anticoagulant therapy

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

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