REGistry of Long-term AnTithrombotic TherApy-2

Atrial Fibrillation Clinical Trial

— REGATTA-2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04347187
• Other study ID #: REGATTA203121975
• Status: Recruiting
• Start date: January 15, 2015
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2020
• Source: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
• Contact: Ekaterina Kropacheva, PhD
• Phone: +79166760695
• Email: katekrab[@]list.ru
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Anticoagulants
oral anticoagulants, dual or triple antithrombotic theraphy

Locations

Country	Name	City	State
Russian Federation	National Medical Research Center for Cardiology, Ministry of Health of Russian Federation	Moscow

Sponsors (1)

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

Country where clinical trial is conducted

Russian Federation, 

References & Publications (3)

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 Feb 6. doi: 10.1038/s41397-020-0157-2. [Epub ahead of print] — View Citation

Schjerning Olsen AM, McGettigan P, Gerds TA, Fosbøl EL, Olesen JB, Sindet-Pedersen C, Staerk L, Hansen ML, Pallisgaard JL, Køber 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. 2019 Nov 19. pii: pvz069. doi: 10.1093/ehjcvp/pvz069. [Epub ahead of print] — View Citation

van Rein N, Heide-Jørgensen U, Lijfering WM, Dekkers OM, Sørensen 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composite of major cardiovascular events	stroke, myocardial infarction, stent thrombosis [definite or probable], or urgent revascularization, cqrdiac death	unclusion up to 5 years
Primary	composite of any bleeding events	major, clinically relevant nonmajor, minor (BARC, ISTH,GARFIELD AF)	unclusion up to 5 years
Secondary	Mutations in following genes	CYP2C9*, VKORC1	inclusion