REGistry of Long-term AnTithrombotic TherApy-1

Recruiting

• Conditions: Peripheral Artery Disease; Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))

• Registration Number: NCT04347200
• Lead Sponsor: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation

Brief Summary

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

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 chronic coronary syndromes

Study Timeline

• Study Start: 2015-01-15
• Study First Submitted: 2020-04-10
• Study First Submitted QC: 2020-04-14
• Study First Posted: 2020-04-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-18
• Primary Completion: 2026-01-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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 -

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
composite of major adverse cardiovascular events (MACE)	inclusion up to 5 years	stroke, myocardial infarction, stent thrombosis \[definite or probable\], or urgent revascularization, cardiac death
composite of any bleeding events	inclusion up to 5 years	major, clinically relevant nonmajor, minor (BARC, ISTH)

Secondary Outcome Measures

Name	Time	Method
Severity of peripheral atherosclerosis	inclusion	Assessment will be performed with the use of duplex scanning
Mutations in following genes	inclusion	CYP2C19\*, ABCB1

Trial Locations

Locations (1)

National Medical Research Center for Cardiology, Ministry of Health of Russian Federation; 🇷🇺 Moscow, Russian Federation