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NCT Number: NCT04347200

REGistry of Long-term AnTithrombotic TherApy-1

To assess the rates of ischemic and hemorrhagic complications of long-term antithrombotic therapy in patients with chronic coronary syndromes

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Key information

Conditions

Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)) Angina Pectoris Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chest Pain Coronary Artery Disease Coronary Disease Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Artery Disease Peripheral Vascular Diseases 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

Alla Shuleshova, PhD

SUB_INVESTIGATOR

Andrey Komarov, PhD

SUB_INVESTIGATOR

Elena Yarovaya, PhD

SUB_INVESTIGATOR

Elizaveta Panchenko, PhD

PRINCIPAL_INVESTIGATOR

Olga Shakhmatova, 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 chronic coronary syndromes

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • coronary artery disease , confirmed by history of myocardial infarction, or revascularization, or definitive evidence of CAD on imaging

Exclusion criteria

  • Subjects who are unwilling or unable to provide informed consent.
  • Acute coronary syndrome within 12 months before inclusion
  • Severe chronic heart failure (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

Antiplatelet Drug

Drug

single or dual antiplatelets, triple antithrombotic therapy

Other names: anticoagulant Drug

Primary outcomes

  1. composite of major adverse cardiovascular events (MACE)

    Time frame: inclusion up to 5 years

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

  2. composite of any bleeding events

    Time frame: inclusion up to 5 years

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

Secondary outcomes

  1. Severity of peripheral atherosclerosis

    Time frame: inclusion

    Assessment will be performed with the use of duplex scanning

  2. Mutations in following genes

    Time frame: inclusion

    CYP2C19*, ABCB1

Study contacts

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

Andrey Komarov, PhD

CONTACT

[email protected]

+79161813257

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 Chronic Coronary Syndromes

Acronym: REGATTA-1

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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