AzTrials
AzTrials

Atrial FibrillationREGATTA-2NCT04347187

REGistry of Long-term AnTithrombotic TherApy-2

An observational study of Atrial Fibrillation, run by National Medical Research Center for Cardiology, Ministry of Health of Russian Federation at 1 site in Russia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

To assess the rates of ischemic and hemorrhagic complications of long-term antithrombotic therapy in patients with atrial fibrillation Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
Anticoagulants
Type of treatment
Pill or oral medicine
How many people
2,000 participants
Where
1 siteRussia
Study dates
15 Jan 2015to 31 Dec 2026
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Hospitalized or outpatients with confirmed atrial fibrillation and CHA2DS2VASC > 1

Who may be able to join

  • Documented atrial fibrillation with CHA2DS2VASC > 1

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ekaterina Kropacheva, PhD contact

+79166760695

katekrab@list.ru

Russia1 site, 1 recruiting

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

    Moscow, 121552

    Elizaveta Panchenko, PhD

    Ekaterina Kropacheva, PhD

    Recruiting

Other trials in Russia

About this study

Official title: 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

Read the 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

Being tested
Anticoagulants
Keywords
atrial fibrillation, coronary artery disease
Medical subject headings
Atrial Fibrillation, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AnticoagulantsDrug

    Also called antiplatelets

    oral anticoagulants, dual or triple antithrombotic theraphy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. composite of major cardiovascular events

    stroke, myocardial infarction, stent thrombosis [definite or probable], or urgent revascularization, cqrdiac death

    Measured: unclusion up to 5 years

  2. composite of any bleeding events

    major, clinically relevant nonmajor, minor (BARC, ISTH,GARFIELD AF)

    Measured: unclusion up to 5 years

Secondary outcomes (1)

  1. Mutations in following genes

    CYP2C9*, VKORC1

    Measured: inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2020
  2. Study start15 Jan 2015
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,000 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04347187
Sponsor's protocol ID
REGATTA203121975
Acronym
REGATTA-2
Status last verified
Apr 2026
First submitted
10 Apr 2020
Last updated
1 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in the article after deidentification (text, tables, figures)

Publications

  • van Rein N, Heide-Jorgensen U, Lijfering WM, Dekkers OM, Sorensen HT, Cannegieter SC. Major Bleeding Rates in Atrial Fibrillation Patients on Single, Dual, or Triple Antithrombotic Therapy. Circulation. 2019 Feb 5;139(6):775-786. doi: 10.1161/CIRCULATIONAHA.118.036248.

    PubMed 30586754

  • Olsen AS, McGettigan P, Gerds TA, Fosbol EL, Olesen JB, Sindet-Pedersen C, Staerk L, Lock Hansen M, Pallisgaard JL, Kober L, Torp-Pedersen C, Gislason GH, Lamberts M. Risk of gastrointestinal bleeding associated with oral anticoagulation and non-steroidal anti-inflammatory drugs in patients with atrial fibrillation: a nationwide study. Eur Heart J Cardiovasc Pharmacother. 2020 Sep 1;6(5):292-300. doi: 10.1093/ehjcvp/pvz069.

    PubMed 31742339

  • Panchenko E, Kropacheva E, Dobrovolsky A, Titaeva E, Zemlyanskaya O, Trofimov D, Galkina I, Lifshits G, Vereina N, Sinitsin S, Vorobyeva N, Grehova L, Zateyshchikov D, Zotova I, Vavilova T, Sirotkina O, Grontkovskaya A. CYP2C9 and VKORC1 genotyping for the quality of long-standing warfarin treatment in Russian patients. Pharmacogenomics J. 2020 Oct;20(5):687-694. doi: 10.1038/s41397-020-0157-2. Epub 2020 Feb 6.

    PubMed 32024944

  • Kropacheva ES, Khakimova MB, Krivosheeva EN, Zemlyanskaya OA, Panchenko EP. [Severe gastrointestinal bleeding in patients with atrial fibrillation receiving oral anticoagulants (based on REGistry of long-term AnTithrombotic TherApy - REGATTA)]. Ter Arkh. 2021 Sep 15;93(9):1037-1043. doi: 10.26442/00403660.2021.09.201019. Russian.

    PubMed 36286862

  • Mironova Staroverova AI, Panchenko EP, Kropacheva ES, Zemlyanskaya OA. [Resumption of anticoagulant therapy after major bleeding and recurrence of hemorrhagic complications in patients with atrial fibrillation with a high risk of stroke and thromboembolism (based on the results of 20 years of observation)]. Ter Arkh. 2020 Oct 14;92(9):15-23. doi: 10.26442/00403660.2020.09.000655. Russian.

    PubMed 33346426

  • Krivosheeva EN, Panchenko EP, Kropacheva ES, Dobrovolsky AB, Titaeva EV, Mironov VM, Samko AN. Prediction-Determining Outcomes and Their Predictors in Atrial Fibrillation Patients Receiving Multicomponent Antithrombotic Therapy in Real Clinical Practice. Kardiologiia. 2020 Sep 17;60(8):33-45. doi: 10.18087/cardio.2020.8.n1123.

    PubMed 33155957

  • Krivosheeva EN, Kropacheva ES, Panchenko EP, Samko AN. [Thrombotic and hemorrhagic complications in atrial fibrillation patients, undergoing elective percutaneous coronary intervention]. Ter Arkh. 2019 Sep 15;91(9):38-46. doi: 10.26442/00403660.2019.09.000297. Russian.

    PubMed 32598813

  • Kropacheva ES, Zemlyanskaya OA, Krivosheeva EN, Panchenko EP. [Resumption of anticoagulant therapy after major bleeding and the risk of negative events in patients with atrial fibrillation (based on REGistry of Long-term AnTithrombotic TherApy-2 - REGATA)]. Ter Arkh. 2023 Jan 16;94(12):1374-1380. doi: 10.26442/00403660.2022.12.201994. Russian.

    PubMed 37167181

  • Krivosheeva EN, Komarov AL, Panchenko EP, Khakimova MB, Kropacheva ES, Pogorelova OA, Balakhonova TV, Titaeva EV, Dobrovolsky AB, Galyautdinov DM, Vlasova EE. [GDF-15 and the risk of bleeding in patients with stable CAD receiving multicomponent antithrombotic therapy: the results of the prospective REGATA register]. Ter Arkh. 2024 Jul 30;96(7):683-689. doi: 10.26442/00403660.2024.07.202783. Russian.

    PubMed 39106511

  • Kropacheva ES, Zemlyanskaya OA, Panchenko EP. Chronic Kidney Disease is a Predictor of Recurrent Bleeding in Patients With Atrial Fibrillation After Resuming Anticoagulant Therapy (based on REGistry of Long-term AnTithrombotic TherApy (REGATA-2). Kardiologiia. 2023 Nov 8;63(10):55-62. doi: 10.18087/cardio.2023.10.n2284. English, Russian.

    PubMed 37970856

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation, run by National Medical Research Center for Cardiology, Ministry of Health of Russian Federation at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ekaterina Kropacheva, PhD (+79166760695, katekrab@list.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

composite of major cardiovascular events (time frame: unclusion up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04347187, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in