REGistry of Long-term AnTithrombotic TherApy-1

Peripheral Artery Disease Clinical Trial

— REGATTA-1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04347200
• Other study ID #: REGATTA119021970
• Status: Recruiting
• Start date: January 15, 2015
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2020
• Source: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
• Contact: Andrey Komarov, PhD
• Phone: +79161813257
• Email: andrkomarov[@]mail.ru
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 -

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Russian Federation	National Medical Research Center for Cardiology, Ministry of Health of Russian Federation	Moscow

Sponsors (1)

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

Country where clinical trial is conducted

Russian Federation, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	composite of any bleeding events	major, clinically relevant nonmajor, minor (BARC, ISTH)	inclusion up to 5 years
Secondary	Severity of peripheral atherosclerosis	Assessment will be performed with the use of duplex scanning	inclusion
Secondary	Mutations in following genes	CYP2C19*, ABCB1	inclusion