REGistry of Long-term AnTithrombotic TherApy-2 (REGATTA-2)

April 27, 2026 updated by: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation

Registry Dedicated to Assess the Risk of Ischemic and Hemorrhagic Complications of Long-term Antithrombotic Therapy in Patients With Atrial Fibrillation

To assess the rates of ischemic and hemorrhagic complications of long-term antithrombotic therapy in patients with atrial fibrillation

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The register is a Russian prospective single-center observational study of patients who have indications for long-term antithrombotic therapy in connection with atrial fibrillation

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ekaterina Kropacheva, PhD
  • Phone Number: +79166760695
  • Email: katekrab@list.ru

Study Locations

  • Russia
      • Moscow, Russia, 121552
        • Recruiting
        • National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
        • Sub-Investigator:
          • Ekaterina Kropacheva, PhD
        • Sub-Investigator:
          • Oksana Zemlyanskaya, PhD
        • Principal Investigator:
          • Elizaveta Panchenko, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Hospitalized or outpatients with confirmed atrial fibrillation and CHA2DS2VASC > 1

Description

Inclusion Criteria:

  • Documented atrial fibrillation with CHA2DS2VASC > 1

Exclusion Criteria:

  • Subjects who are unwilling or unable to provide informed consent. ACS within 12 months before inclusion Severe CHF (NYHA IV) Stroke within 6 months before inclusion Severe liver or muscle disease Severe kidney disease / renal failure with creatinine > 3 mg/dl Conceivable impossibility to come in touch with the patient or his family at 1-year after the intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
composite of major cardiovascular events
Time Frame: unclusion up to 5 years
stroke, myocardial infarction, stent thrombosis [definite or probable], or urgent revascularization, cqrdiac death
unclusion up to 5 years
composite of any bleeding events
Time Frame: unclusion up to 5 years
major, clinically relevant nonmajor, minor (BARC, ISTH,GARFIELD AF)
unclusion up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mutations in following genes
Time Frame: inclusion
CYP2C9*, VKORC1
inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Medical Research Center for Cardiology, Ministry of Health of Russian Federation

Investigators

  • Principal Investigator: Elizaveta Panchenko, PhD, National Medical Research Center for Cardiology, Ministry of Health of Russian Federation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2015

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 10, 2020

First Submitted That Met QC Criteria

April 14, 2020

First Posted (Actual)

April 15, 2020

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REGATTA203121975

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in the article after deidentification (text, tables, figures)

IPD Sharing Time Frame

Beginning 9 months and ending 36 months following publication

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal . For individual participant data meta-analysis.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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