REGistry of Long-term AnTithrombotic TherApy-1

Overview

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

Full Title of Study: “Registry Dedicated to Assess the Risk of Ischemic and Hemorrhagic Complications of Long-term Antithrombotic Therapy in Patients With Chronic Coronary Syndromes”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 2025

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

Interventions

  • Drug: Antiplatelet Drug
    • single or dual antiplatelets, triple antithrombotic theraphy

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • composite of any bleeding events
    • Time Frame: inclusion up to 5 years
    • major, clinically relevant nonmajor, minor (BARC, ISTH)

Secondary Measures

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

Participating in This Clinical Trial

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 -

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
  • Provider of Information About this Clinical Study
    • Principal Investigator: Elizaveta Panchenko, professor – National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
  • Overall Official(s)
    • Elizaveta Panchenko, PhD, Principal Investigator, National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
  • Overall Contact(s)
    • Andrey Komarov, PhD, +79161813257, andrkomarov@mail.ru

References

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, Störk 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, Röther 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.

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.

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