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NCT Number: NCT04347187

REGistry of Long-term AnTithrombotic TherApy-2

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Moscow, 121552, Russia

Location status: Recruiting

Location contact

Ekaterina Kropacheva, PhD

SUB_INVESTIGATOR

Elizaveta Panchenko, PhD

PRINCIPAL_INVESTIGATOR

Oksana Zemlyanskaya, PhD

SUB_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anticoagulants

Drug

oral anticoagulants, dual or triple antithrombotic theraphy

Other names: antiplatelets

Primary outcomes

  1. composite of major cardiovascular events

    Time frame: unclusion up to 5 years

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

  2. composite of any bleeding events

    Time frame: unclusion up to 5 years

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

Secondary outcomes

  1. Mutations in following genes

    Time frame: inclusion

    CYP2C9*, VKORC1

Study contacts

Contact information is provided by the study sponsor or research team.

Ekaterina Kropacheva, PhD

CONTACT

[email protected]

+79166760695

Sponsors and collaborators

Lead sponsor

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

Other Gov

Registry information

Official study title

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

Acronym: REGATTA-2

Important dates

Study start
2015
Primary completion
2026
Study completion
2026
First posted
Apr 15, 2020
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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