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Second-generation Drug-eluting Stents in Diabetes (SUGAR)

Primary Purpose

Coronary Artery Disease, Diabetes Mellitus

Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Polymer-free amphilimus-eluting stents
Biolinx Polymer-based zotarolimus-eluting stents
Sponsored by
Spanish Society of Cardiology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, Diabetes Mellitus, Drug-eluting stents, Restenosis

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Universitari de Bellvitge
  • Hospital General Universitario de Alicante
  • Hospital San Juan
  • Hospital Clinic de Barcelona
  • Hospital de la Santa Creu i Sant Pau
  • Hospital del Mar
  • Hospital Vall d'Hebrón
  • Hospital Reina Sofía
  • Hospital Juan Ramón Jiménez
  • Hospital Doctor Negrín
  • Hospital Universitario de León
  • Hospital Lucus Augusti
  • Hospital Clínico San Carlos
  • Clínica Universidad de Navarra
  • Hospital Virgen de la Arrixaca
  • Hospital Universitario Son Espases
  • Hospital Marqués de Valdecilla
  • Hospital de Santiago
  • Hospital Joan XXIII
  • Hospital Universitario de Canarias
  • Hospital Virgen de la Salud
  • Hospital Clínico de Valencia
  • Hospital Álvaro Cunqueiro

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Amphilimus-eluting stents

Zotarolimus-eluting stents

Arm Description

Polymer-free Amphilimus-eluting stents

Biolinx Polymer-based zotarolimus-eluting stents

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Cardiac death
Target vessel myocardial infarction
Target vessel revascularization
Target lesion revascularization
Stent thrombosis
Academic Research Consortium definitions
Non-target lesion revascularization

Full Information

First Posted
October 22, 2017
Last Updated
January 14, 2021
Sponsor
Spanish Society of Cardiology
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1. Study Identification

Unique Protocol Identification Number
NCT03321032
Brief Title
Second-generation Drug-eluting Stents in Diabetes
Acronym
SUGAR
Official Title
Second-generation drUg-elutinG Stents in diAbetes: a Randomized Trial (the SUGAR Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 19, 2017 (Actual)
Primary Completion Date
January 28, 2021 (Anticipated)
Study Completion Date
January 28, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spanish Society of Cardiology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Diabetes Mellitus
Keywords
Coronary Artery Disease, Diabetes Mellitus, Drug-eluting stents, Restenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1164 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Amphilimus-eluting stents
Arm Type
Experimental
Arm Description
Polymer-free Amphilimus-eluting stents
Arm Title
Zotarolimus-eluting stents
Arm Type
Active Comparator
Arm Description
Biolinx Polymer-based zotarolimus-eluting stents
Intervention Type
Device
Intervention Name(s)
Polymer-free amphilimus-eluting stents
Intervention Description
Cre8 Evo coronary stent system (CID, Saluggia, Italy)
Intervention Type
Device
Intervention Name(s)
Biolinx Polymer-based zotarolimus-eluting stents
Intervention Description
Resolute Onyx coronary stent system (Medtronic, Minneapolis, Minnesota, US)
Primary Outcome Measure Information:
Title
Target lesion failure at 1-year follow-up
Description
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.
Time Frame
12 months
Title
Target lesion failure at 2-years follow-up
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Cardiac death
Time Frame
12 and 24 months
Title
Target vessel myocardial infarction
Time Frame
12 and 24 months
Title
Target vessel revascularization
Time Frame
12 and 24 months
Title
Target lesion revascularization
Time Frame
12 and 24 months
Title
Stent thrombosis
Description
Academic Research Consortium definitions
Time Frame
12 and 24 months
Title
Non-target lesion revascularization
Time Frame
12 and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hospital Universitari de Bellvitge
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital General Universitario de Alicante
City
Alicante
Country
Spain
Facility Name
Hospital San Juan
City
Alicante
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
Country
Spain
Facility Name
Hospital Vall d'Hebrón
City
Barcelona
Country
Spain
Facility Name
Hospital Reina Sofía
City
Córdoba
Country
Spain
Facility Name
Hospital Juan Ramón Jiménez
City
Huelva
Country
Spain
Facility Name
Hospital Doctor Negrín
City
Las Palmas De Gran Canaria
Country
Spain
Facility Name
Hospital Universitario de León
City
León
Country
Spain
Facility Name
Hospital Lucus Augusti
City
Lugo
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Clínica Universidad de Navarra
City
Madrid
Country
Spain
Facility Name
Hospital Virgen de la Arrixaca
City
Murcia
Country
Spain
Facility Name
Hospital Universitario Son Espases
City
Palma De Mallorca
Country
Spain
Facility Name
Hospital Marqués de Valdecilla
City
Santander
Country
Spain
Facility Name
Hospital de Santiago
City
Santiago De Compostela
Country
Spain
Facility Name
Hospital Joan XXIII
City
Tarragona
Country
Spain
Facility Name
Hospital Universitario de Canarias
City
Tenerife
Country
Spain
Facility Name
Hospital Virgen de la Salud
City
Toledo
Country
Spain
Facility Name
Hospital Clínico de Valencia
City
Valencia
Country
Spain
Facility Name
Hospital Álvaro Cunqueiro
City
Vigo
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
32087418
Citation
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.
Results Reference
result
PubMed Identifier
34735004
Citation
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.
Results Reference
derived

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Second-generation Drug-eluting Stents in Diabetes

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