REGistry of Long-term AnTithrombotic TherApy-1 (REGATTA-1)

Registry Dedicated to Assess the Risk of Ischemic and Hemorrhagic Complications of Long-term Antithrombotic Therapy in Patients With Chronic Coronary Syndromes

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

Study Overview

• Status: Recruiting
• Conditions: Peripheral Artery Disease; Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
• Intervention / Treatment: Drug: Antiplatelet Drug

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 Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Andrey Komarov, PhD; Phone Number: +79161813257; Email: andrkomarov@mail.ru

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 121552
    • Recruiting
    • National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
    • Sub-Investigator: Olga Shakhmatova, PhD
    • Sub-Investigator: Andrey Komarov, PhD
    • Sub-Investigator: Elena Yarovaya, PhD
    • Sub-Investigator: Alla Shuleshova, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Hospitalized or outpatients with confirmed chronic coronary syndromes

Description

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.
• 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 -

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of peripheral atherosclerosis	Assessment will be performed with the use of duplex scanning	inclusion
Mutations in following genes	CYP2C19*, ABCB1	inclusion

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Eikelboom JW, Connolly SJ, Bosch J, Dagenais GR, Hart RG, Shestakovska O, Diaz R, Alings M, Lonn EM, Anand SS, Widimsky P, Hori M, Avezum A, Piegas LS, Branch KRH, Probstfield J, Bhatt DL, Zhu J, Liang Y, Maggioni AP, Lopez-Jaramillo P, O'Donnell M, Kakkar AK, Fox KAA, Parkhomenko AN, Ertl G, Stork S, Keltai M, Ryden L, Pogosova N, Dans AL, Lanas F, Commerford PJ, Torp-Pedersen C, Guzik TJ, Verhamme PB, Vinereanu D, Kim JH, Tonkin AM, Lewis BS, Felix C, Yusoff K, Steg PG, Metsarinne KP, Cook Bruns N, Misselwitz F, Chen E, Leong D, Yusuf S; COMPASS Investigators. Rivaroxaban with or without Aspirin in Stable Cardiovascular Disease. N Engl J Med. 2017 Oct 5;377(14):1319-1330. doi: 10.1056/NEJMoa1709118. Epub 2017 Aug 27.
• Darmon A, Sorbets E, Ducrocq G, Elbez Y, Abtan J, Popovic B, Ohman EM, Rother J, Wilson PF, Montalescot G, Zeymer U, Bhatt DL, Steg PG; REACH Registry Investigators. Association of Multiple Enrichment Criteria With Ischemic and Bleeding Risks Among COMPASS-Eligible Patients. J Am Coll Cardiol. 2019 Jul 2;73(25):3281-3291. doi: 10.1016/j.jacc.2019.04.046.
• Komarov A, Panchenko E, Dobrovolsky A, Karpov Y, Deev A, Titaeva E, Davletov K, Eshkeeva A, Markova L. D-dimer and platelet aggregability are related to thrombotic events in patients with peripheral arterial occlusive disease. Eur Heart J. 2002 Aug;23(16):1309-16. doi: 10.1053/euhj.2001.3116.
• Komarov AL, Shakhmatova OO, Muraseeva VG, Novikova ES, Guskova EV, Panchenko EP. Proton pump inhibitors receiving and prognosis of patients after scheduled percutaneous coronary interventions. Ter Arkh. 2018 Sep 20;90(9):92-100. doi: 10.26442/terarkh201890992-100.
• Darmon A, Bhatt DL, Elbez Y, Aboyans V, Anand S, Bosch J, Branch KR, Connolly SJ, Dyal L, Eikelboom JW, Fox KAA, Keltai K, Probstfield J, Yusuf S, Abtan J, Sorbets E, Eagle KA, Ducrocq G, Steg PG. External applicability of the COMPASS trial: an analysis of the reduction of atherothrombosis for continued health (REACH) registry. Eur Heart J. 2018 Mar 1;39(9):750-757a. doi: 10.1093/eurheartj/ehx658.
• Shakhmatova OO, Komarov AL, Korobkova VV, Yarovaya EB, Andreevskaya MV, Shuleshova AG, Panchenko EP. [Upper gastrointestinal bleeding in patients with stable coronary artery disease (registry of antithrombotic therapy "REGATcapital TE, CyrillicA" results)]. Ter Arkh. 2020 Oct 14;92(9):30-38. doi: 10.26442/00403660.2020.09.000699. Russian.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 15, 2015
• Primary Completion (ANTICIPATED): December 31, 2025
• Study Completion (ANTICIPATED): December 31, 2025

Study Registration Dates

• First Submitted: April 10, 2020
• First Submitted That Met QC Criteria: April 14, 2020
• First Posted (ACTUAL): April 15, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 15, 2020
• Last Update Submitted That Met QC Criteria: April 14, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Coronary Artery Disease, Peripheral Artery Disease
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Myocardial Infarction; Infarction; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Peripheral Arterial Disease; Anticoagulants; Platelet Aggregation Inhibitors
• Other Study ID Numbers: REGATTA119021970

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in the article after deidentification (text, tables, figures)
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following publication
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal . For individual participant data meta-analysis.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No