Clinical trial NCT04347187: REGistry of Long-term AnTithrombotic TherApy-2
Official title: Registry Dedicated to Assess the Risk of Ischemic and Hemorrhagic Complications of Long-term Antithrombotic Therapy in Patients With Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation, coronary artery disease
Lead sponsor: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Sponsor class: OTHER_GOV
First posted: 2020-04-15
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized or outpatients with confirmed atrial fibrillation and CHA2DS2VASC \> 1

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

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

Eligibility criteria: 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

Primary outcomes:
measure: composite of major cardiovascular events
timeFrame: unclusion up to 5 years
measure: composite of any bleeding events
timeFrame: unclusion up to 5 years
Secondary outcomes:
measure: Mutations in following genes
timeFrame: inclusion
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Study officials:
affiliation: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
name: Elizaveta Panchenko, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.