Second-generation Drug-eluting Stents in Diabetes
SUGAR
Second-generation drUg-elutinG Stents in diAbetes: a Randomized Trial (the SUGAR Trial)
1 other identifier
interventional
1,164
1 country
23
Brief Summary
This is an investigator initiated randomized trial, performed under the auspices of the Spanish Society of Cardiology. 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 coronary-artery-disease
Started Dec 2017
Typical duration for phase_4 coronary-artery-disease
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2017
CompletedFirst Posted
Study publicly available on registry
October 25, 2017
CompletedStudy Start
First participant enrolled
December 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 28, 2022
CompletedJanuary 19, 2021
January 1, 2021
3.1 years
October 22, 2017
January 14, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Target lesion failure at 1-year follow-up
A composite of cardiac death, any myocardial infarction (not clearly attributable to a non-target vessel), or clinically indicated target-lesion revascularization at 12-months follow-up.
12 months
Target lesion failure at 2-years follow-up
A composite of cardiac death, any myocardial infarction (not clearly attributable to a non-target vessel), or clinically indicated target-lesion revascularization at 24-months follow-up.
24 months
Secondary Outcomes (6)
Cardiac death
12 and 24 months
Target vessel myocardial infarction
12 and 24 months
Target vessel revascularization
12 and 24 months
Target lesion revascularization
12 and 24 months
Stent thrombosis
12 and 24 months
- +1 more secondary outcomes
Study Arms (2)
Amphilimus-eluting stents
EXPERIMENTALPolymer-free Amphilimus-eluting stents
Zotarolimus-eluting stents
ACTIVE COMPARATORBiolinx Polymer-based zotarolimus-eluting stents
Interventions
Cre8 Evo coronary stent system (CID, Saluggia, Italy)
Resolute Onyx coronary stent system (Medtronic, Minneapolis, Minnesota, US)
Eligibility Criteria
You may qualify if:
- Patients ≥18 years who understands the nature of the study and provides written informed consent.
- 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).
You may not qualify if:
- Cardiogenic shock or resuscitation
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, 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, 28040, 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
Related Publications (3)
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.
PMID: 32087418RESULTSalinas 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 Nov 25;111(24):1191-1198. doi: 10.1136/heartjnl-2025-325773.
PMID: 40562528DERIVEDRomaguera 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.
PMID: 34735004DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 22, 2017
First Posted
October 25, 2017
Study Start
December 19, 2017
Primary Completion
January 28, 2021
Study Completion
January 28, 2022
Last Updated
January 19, 2021
Record last verified: 2021-01