REGistry of Long-term AnTithrombotic TherApy-1

NCT04347200 | Recruiting

• 1 other identifier: REGATTA119021970
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Coronary Artery Disease, Peripheral Artery Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Severity of peripheral atherosclerosis

  inclusion

• Mutations in following genes

  inclusion

Interventions

Antiplatelet Drug DRUG

single or dual antiplatelets, triple antithrombotic therapy

Also known as: anticoagulant Drug

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized or outpatients with confirmed chronic coronary syndromes

You may qualify if:

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

You may not qualify if:

• Subjects who are unwilling or unable to provide informed consent.
• Severe chronic heart failure (NYHA IV)
• 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 -

Sponsors & Collaborators

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

Study Sites (1)

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

Moscow, 121552, Russia

RECRUITING

Related Publications (9)

• Komarov AL, Shakhmatova OO, Korobkova VV. [The balance of benefit and risk in prescribing antithrombotic therapy for patients with coronary artery disease. How to deal with the gastrointestinal bleeding problem?]. Kardiologiia. 2020 Aug 11;60(7):115-124. doi: 10.18087/cardio.2020.7.n1159. Russian.

  PMID: 33155950 BACKGROUND

• Shakhmatova OO, Komarov AL, Krivosheeva EN, Dobrovolsky AB, Titaeva EV, Amelyushkina VA, Gomyranova NV, Panchenko EP. [Albuminuria as a marker of atherosclerosis burden and a possible predictor of adverse events in patients with polyvascular disease]. Ter Arkh. 2023 Nov 3;95(9):763-768. doi: 10.26442/00403660.2023.09.202434. Russian.

  PMID: 38158919 BACKGROUND

• 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.

  PMID: 28844192 BACKGROUND

• 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.

  PMID: 31248549 BACKGROUND

• 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.

  PMID: 12175668 BACKGROUND

• 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.

  PMID: 30701742 BACKGROUND

• 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.

  PMID: 29186454 BACKGROUND

• Komarov AL, Shahmatova OO, Korobkova VV, Kurilina EV, Shuleshova AG, Panchenko EP. [Gastric mucosa condition in patients with coronary artery disease and high risk of gastrointestinal bleeding (register REGATTA-1)]. Ter Arkh. 2021 Dec 15;93(12):1457-1462. doi: 10.26442/00403660.2021.12.201224. Russian.

  PMID: 36286673 BACKGROUND

• 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.

  PMID: 33346428 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, white cells, urine

MeSH Terms

Conditions

Coronary Artery Disease; Angina Pectoris; Myocardial Infarction; Peripheral Arterial Disease

Interventions

Platelet Aggregation Inhibitors; Anticoagulants

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Pathologic Processes; Necrosis; Atherosclerosis; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Elizaveta Panchenko, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrey Komarov, PhD

CONTACT

+79161813257; andrkomarov@mail.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 15, 2020
• Study Start: January 15, 2015
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)