Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
1164 participants
INTERVENTIONAL
2017-12-19
2022-01-28
Brief Summary
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It is a multicenter, international, parallel, randomized 1:1 (amphilimus-eluting stents vs zotarolimus-eluting stents) clinical trial performed exclusively in patients with diabetes mellitus. The study has an "all-comers diabetics" design.
The primary-endpoint is target lesion failure at 1-year follow-up (non-inferiority design) and the co-primary end-point is target lesion failure at 2-years follow-up (superiority-design).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Amphilimus-eluting stents
Polymer-free Amphilimus-eluting stents
Polymer-free amphilimus-eluting stents
Cre8 Evo coronary stent system (CID, Saluggia, Italy)
Zotarolimus-eluting stents
Biolinx Polymer-based zotarolimus-eluting stents
Biolinx Polymer-based zotarolimus-eluting stents
Resolute Onyx coronary stent system (Medtronic, Minneapolis, Minnesota, US)
Interventions
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Polymer-free amphilimus-eluting stents
Cre8 Evo coronary stent system (CID, Saluggia, Italy)
Biolinx Polymer-based zotarolimus-eluting stents
Resolute Onyx coronary stent system (Medtronic, Minneapolis, Minnesota, US)
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of diabetes according to the American Diabetes Association diagnostic criteria (\*)
* Documented silent ischemia, stable angina, unstable angina, or myocardial infarction (with or without ST elevation).
* At least one de novo coronary lesion with stenosis of more than 50% in a vessel with a reference vessel diameter of 2.25 to 4.5 mm by visual estimation. Coronary anatomy is suitable for PCI (patients with potential CABG indication should be eligible for PCI after a multidisciplinary evaluation in a Heart Team).
Exclusion Criteria
* Comorbidity with anticipated life expectancy to 24 months
* Inability to consent due to mechanical ventilation
* Pregnant female patient
* Conditions that could preclude a minimal of 1 month of DAPT (such as, but not limited to: severe liver failure, platelet count \<100,000 cells/mm3, recent gastrointestinal bleeding or history of bleeding diathesis or coagulopathy)
* Contraindication or known allergy to aspirin, heparin, P2Y12 inhibitors, cobalt and/or chromium metal alloys, sirolimus or derivates, polyurethane, or contrast media (for contrast-media allergy, patients that might be safely and adequately pre-medicated should be allowed to enter the study).
* Currently enrolled in another clinical trial.
18 Years
100 Years
ALL
No
Sponsors
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Spanish Society of Cardiology
OTHER
Responsible Party
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Dr Rafael Romaguera
Principal Investigator
Locations
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Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital General Universitario de Alicante
Alicante, , Spain
Hospital San Juan
Alicante, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital Vall d'Hebrón
Barcelona, , Spain
Hospital Reina Sofía
Córdoba, , Spain
Hospital Juan Ramón Jiménez
Huelva, , Spain
Hospital Doctor Negrín
Las Palmas de Gran Canaria, , Spain
Hospital Universitario de León
León, , Spain
Hospital Lucus Augusti
Lugo, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Clínica Universidad de Navarra
Madrid, , Spain
Hospital Virgen de la Arrixaca
Murcia, , Spain
Hospital Universitario Son Espases
Palma de Mallorca, , Spain
Hospital Universitario de Canarias
Santa Cruz de Tenerife, , Spain
Hospital Marqués de Valdecilla
Santander, , Spain
Hospital de Santiago
Santiago de Compostela, , Spain
Hospital Joan XXIII
Tarragona, , Spain
Hospital Virgen de la Salud
Toledo, , Spain
Hospital Clínico de Valencia
Valencia, , Spain
Hospital Álvaro Cunqueiro
Vigo, , Spain
Countries
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References
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Romaguera R, Salinas P, Brugaletta S, Gomez-Lara J, Diaz JF, Romero MA, Garcia-Blas S, Ocaranza R, Borde P, Jimenez Kockar M, Millan Segovia R, Iniguez A, Alameda M, Trillo R, Lee DH, Martin P, Lopez-Benito M, Frutos A, Moreu J, Hernandez-Hernandez F, Garcia Del Blanco B, Roura G, Rossello X, Pocock SJ, Fernandez-Ortiz A, Sabate M, Gomez-Hospital JA. Second-Generation Drug-Eluting Stents in Diabetes (SUGAR) trial: Rationale and study design. Am Heart J. 2020 Apr;222:174-182. doi: 10.1016/j.ahj.2020.01.018. Epub 2020 Jan 28. No abstract available.
Salinas P, Romaguera R, Gomez-Lara J, Brugaletta S, Gomez-Menchero A, Martin P, Romero M, Garcia-Blas S, Jimenez M, Jimenez VA, Bordes P, Bayon J, Salvatella N, Alameda M, Hyun-Lee D, Trillo-Nouche R, Lopez-Benito M, Frutos A, Moreu J, Garcia Del Blanco B, Mohandes M, Bosa Ojeda F, Hernandez Hernandez F, Pinar-Bermudez E, Jimenez-Quevedo P, Rossello X, Pocock S, Sabate M, Gomez-Hospital JA, Comin-Colet J, Gonzalo N, Fernandez Ortiz A; SUGAR trial Investigators. Amphilimus-eluting versus zotarolimus-eluting stents in patients with diabetes mellitus and coronary artery disease: extended follow-up of the SUGAR randomised controlled trial. Heart. 2025 Jun 25:heartjnl-2025-325773. doi: 10.1136/heartjnl-2025-325773. Online ahead of print.
Romaguera R, Salinas P, Gomez-Lara J, Brugaletta S, Gomez-Menchero A, Romero MA, Garcia-Blas S, Ocaranza R, Bordes P, Kockar MJ, Salvatella N, Jimenez-Diaz VA, Alameda M, Trillo R, Lee DH, Martin P, Lopez-Benito M, Freites A, Pascual-Tejerina V, Hernandez-Hernandez F, Blanco BGD, Mohandes M, Bosa F, Pinar E, Roura G, Comin-Colet J, Fernandez-Ortiz A, Macaya C, Rossello X, Sabate M, Pocock SJ, Gomez-Hospital JA; SUGAR trial investigators. Amphilimus- vs. zotarolimus-eluting stents in patients with diabetes mellitus and coronary artery disease: the SUGAR trial. Eur Heart J. 2022 Mar 31;43(13):1320-1330. doi: 10.1093/eurheartj/ehab790.
Other Identifiers
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SEC-SUG-2016-01
Identifier Type: -
Identifier Source: org_study_id
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