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RecruitingNCT04347200REGATTA-1Updated May 1, 2026

REGistry of Long-term AnTithrombotic TherApy-1

An observational study in Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)) and Peripheral Artery Disease, sponsored by National Medical Research Center for Cardiology, Ministry of Health of Russian Federation. Recruiting at 1 site in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-01.

Sponsored by National Medical Research Center for Cardiology, Ministry of Health of Russian Federation · Observational

From the registry’s dates

  • Started Jan 2015; still recruiting 11 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

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

Keywords

  • Coronary Artery Disease, Peripheral Artery Disease
03

In context

Coronary Artery Disease

4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 320 across 1,687 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

National Medical Research Center for Cardiology, Ministry of Health of Russian Federation is the lead sponsor of 20 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Hospitalized or outpatients with confirmed chronic coronary syndromes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Subjects who are unwilling or unable to provide .
  • Acute coronary syndrome within 12 months before inclusion
  • Severe chronic heart failure ( 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 -
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Interventions

  • DrugAntiplatelet Drug

    single or dual antiplatelets, triple antithrombotic therapy

    Also known as: anticoagulant Drug

06

What researchers measure

Primary outcomes

  1. composite of major adverse cardiovascular events (MACE)

    stroke, myocardial infarction, stent thrombosis \[definite or probable\], or urgent revascularization, cardiac death

    Time frame: inclusion up to 5 years

  2. composite of any bleeding events

    major, clinically relevant nonmajor, minor (BARC, ISTH)

    Time frame: inclusion up to 5 years

Secondary outcomes

  1. Severity of peripheral atherosclerosis

    Assessment will be performed with the use of duplex scanning

    Time frame: inclusion

  2. Mutations in following genes

    CYP2C19\*, ABCB1

    Time frame: inclusion

07

Study locations

1 of 1 sites recruiting
  • National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
    Moscow, 121552, Russia
    Recruiting
    • Elizaveta Panchenko, PhD · Principal investigator
    • Olga Shakhmatova, PhD · Sub investigator
    • Andrey Komarov, PhD · Sub investigator
    • Elena Yarovaya, PhD · Sub investigator
    • Alla Shuleshova, PhD · Sub investigator
08

References and documents

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. PubMed 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. PubMed 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, 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 36286673 ↗
  • 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. PubMed 33346428 ↗

Individual participant data

Plan to share: No — Individual participant data that underlie the results reported in the article after deidentification (text, tables, figures)

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2015 (actual). Primary completion is estimated for Dec 2026, 143 months after the start.

Of 634 non-industry observational studies under Coronary Artery Disease, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 122. This study's planned 143 months is above that.

Counting every sponsor, half of 759 studies reached it within 40 months; a quarter within 21 and three quarters within 87.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 10, 2020
First posted
Apr 15, 2020
StartActual
Jan 15, 2015
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
May 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04347200
Lead sponsor
National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Responsible party
Sponsor
First posted
Apr 15, 2020
Start date
Jan 15, 2015
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
May 1, 2026

Study contacts

Andrey Komarov, PhD
Contact
andrkomarov@mail.ru
+79161813257
Elizaveta Panchenko, PhD
principal investigator · National Medical Research Center for Cardiology, Ministry of Health of Russian Federation

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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