REGistry of Long-term AnTithrombotic TherApy-2

NCT ID: NCT04347187

Last Updated: 2025-03-21

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

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-15

Study Completion Date

2026-12-31

Brief Summary

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

Detailed Description

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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

Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Anticoagulants

oral anticoagulants, dual or triple antithrombotic theraphy

Intervention Type DRUG

Other Intervention Names

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antiplatelets

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elizaveta Panchenko, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Moscow, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Ekaterina Kropacheva, PhD

Role: CONTACT

+79166760695

References

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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.

Reference Type BACKGROUND
PMID: 30586754 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31742339 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32024944 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36286862 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33346426 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33155957 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32598813 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37167181 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39106511 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37970856 (View on PubMed)

Other Identifiers

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REGATTA203121975

Identifier Type: -

Identifier Source: org_study_id

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