REGistry of Long-term AnTithrombotic TherApy-2

NCT04347187 | Recruiting

• 1 other identifier: REGATTA203121975
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation, coronary artery disease

Outcome Measures

Primary Outcomes (2)

• composite of major cardiovascular events

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

  unclusion up to 5 years

• composite of any bleeding events

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

  unclusion up to 5 years

Secondary Outcomes (1)

• Mutations in following genes

  inclusion

Interventions

Anticoagulants DRUG

oral anticoagulants, dual or triple antithrombotic theraphy

Also known as: antiplatelets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized or outpatients with confirmed atrial fibrillation and CHA2DS2VASC \> 1

You may qualify if:

• Documented atrial fibrillation with CHA2DS2VASC \> 1

Sponsors & Collaborators

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

Study Sites (1)

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

Moscow, 121552, Russia

RECRUITING

Related Publications (10)

• 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.

  PMID: 30586754 BACKGROUND

• 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.

  PMID: 31742339 BACKGROUND

• 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.

  PMID: 32024944 BACKGROUND

• 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.

  PMID: 36286862 BACKGROUND

• 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.

  PMID: 33346426 BACKGROUND

• 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.

  PMID: 33155957 BACKGROUND

• 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.

  PMID: 32598813 BACKGROUND

• 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.

  PMID: 37167181 BACKGROUND

• 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.

  PMID: 39106511 BACKGROUND

• 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.

  PMID: 37970856 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, white cells, urine

MeSH Terms

Conditions

Atrial Fibrillation; Coronary Artery Disease

Interventions

Anticoagulants

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Elizaveta Panchenko, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ekaterina Kropacheva, PhD

CONTACT

+79166760695; katekrab@list.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 15, 2020
• Study Start: January 15, 2015
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 9 months and ending 36 months following publication
• Access Criteria: Researchers who provide a methodologically sound proposal . For individual participant data meta-analysis.

Locations

RU (1)