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Recruiting NCT04347200

REGistry of Long-term AnTithrombotic TherApy-1

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Antiplatelet Drug.
Who it may be relevant to
Registry conditions: Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)), Peripheral Artery Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Russia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Drug Antiplatelet Drug
    single or dual antiplatelets, triple antithrombotic therapy

Primary outcome measures

  • composite of major adverse cardiovascular events (MACE) [Time frame: inclusion up to 5 years]
  • composite of any bleeding events [Time frame: inclusion up to 5 years]
Secondary outcome measures (2)
  • Severity of peripheral atherosclerosis [Time frame: inclusion]
  • Mutations in following genes [Time frame: inclusion]

Eligibility criteria

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 -

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Russia · 1 center
  • National Medical Research Center for Cardiology, Ministry of Health of Russian Federation — Moscow

Publications

  • 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
  • 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
  • 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, Verham PMID 28844192
  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT04347200 · REGATTA119021970

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗