AzTrials
AzTrials

Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))REGATTA-1NCT04347200

REGistry of Long-term AnTithrombotic TherApy-1

An observational study of Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)) and Peripheral Artery Disease, run by National Medical Research Center for Cardiology, Ministry of Health of Russian Federation at 1 site in Russia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
Antiplatelet Drug
How many people
2,000 participants
Where
1 siteRussia
Study dates
15 Jan 2015to 31 Dec 2026
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Hospitalized or outpatients with confirmed chronic coronary syndromes

Who may be able to join

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

Who cannot join

  • 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 -

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Andrey Komarov, PhD contact

+79161813257

andrkomarov@mail.ru

Russia1 site, 1 recruiting

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

    Moscow, 121552

    Elizaveta Panchenko, PhD

    Olga Shakhmatova, PhD

    Recruiting

Other trials in Russia

About this study

Official title: 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

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

Being tested
Antiplatelet Drug
Keywords
Coronary Artery Disease, Peripheral Artery Disease
Medical subject headings
Coronary Artery Disease, Angina Pectoris, Myocardial Infarction, Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Antiplatelet DrugDrug

    Also called anticoagulant Drug

    single or dual antiplatelets, triple antithrombotic therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. composite of major adverse cardiovascular events (MACE)

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

    Measured: inclusion up to 5 years

  2. composite of any bleeding events

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

    Measured: inclusion up to 5 years

Secondary outcomes (2)

  1. Severity of peripheral atherosclerosis

    Assessment will be performed with the use of duplex scanning

    Measured: inclusion

  2. Mutations in following genes

    CYP2C19*, ABCB1

    Measured: inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2020
  2. Study start15 Jan 2015
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,000 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04347200
Sponsor's protocol ID
REGATTA119021970
Acronym
REGATTA-1
Status last verified
Apr 2026
First submitted
10 Apr 2020
Last updated
1 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data that underlie the results reported in the article after deidentification (text, tables, figures)

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

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)) and Peripheral Artery Disease, run by National Medical Research Center for Cardiology, Ministry of Health of Russian Federation at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Andrey Komarov, PhD (+79161813257, andrkomarov@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

composite of major adverse cardiovascular events (MACE) (time frame: inclusion up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04347200, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.

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