Second-generation Drug-eluting Stents in Diabetes

Coronary Artery Disease Clinical Trial

— SUGAR  

Official title:

Second-generation drUg-elutinG Stents in diAbetes: a Randomized Trial (the SUGAR Trial)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03321032
• Other study ID #: SEC-SUG-2016-01
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: December 19, 2017
• Est. completion date: January 28, 2022

Study information

• Verified date: January 2021
• Source: Spanish Society of Cardiology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1164
• Est. completion date: January 28, 2022
• Est. primary completion date: January 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria(must meet all):

• 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).

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Myocardial Ischemia

Intervention

Device:
• 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)

Locations

Country	Name	City	State
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 Universitari de Bellvitge	L'Hospitalet de Llobregat	Barcelona
Spain	Hospital Doctor Negrín	Las Palmas De Gran Canaria
Spain	Hospital Universitario de León	León
Spain	Hospital Lucus Augusti	Lugo
Spain	Clínica Universidad de Navarra	Madrid
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Virgen de la Arrixaca	Murcia
Spain	Hospital Universitario Son Espases	Palma De Mallorca
Spain	Hospital Marqués de Valdecilla	Santander
Spain	Hospital de Santiago	Santiago De Compostela
Spain	Hospital Joan XXIII	Tarragona
Spain	Hospital Universitario de Canarias	Tenerife
Spain	Hospital Virgen de la Salud	Toledo
Spain	Hospital Clínico de Valencia	Valencia
Spain	Hospital Álvaro Cunqueiro	Vigo

Sponsors (1)

Lead Sponsor	Collaborator
Spanish Society of Cardiology

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Romaguera R, Salinas P, Brugaletta S, Gomez-Lara J, Díaz JF, Romero MA, García-Blas S, Ocaranza R, Borde P, Jiménez Kockar M, Millan Segovia R, Íñiguez A, Alameda M, Trillo R, Lee DH, Martín P, López-Benito M, Frutos A, Moreu J, Hernández-Hernández F, Gar — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Cardiac death		12 and 24 months
Secondary	Target vessel myocardial infarction		12 and 24 months
Secondary	Target vessel revascularization		12 and 24 months
Secondary	Target lesion revascularization		12 and 24 months
Secondary	Stent thrombosis	Academic Research Consortium definitions	12 and 24 months
Secondary	Non-target lesion revascularization		12 and 24 months