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

January 14, 2021 updated by: Dr Rafael Romaguera, Spanish Society of Cardiology

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1164

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alicante, Spain
        • Hospital General Universitario de Alicante
      • Alicante, Spain
        • Hospital San Juan
      • Barcelona, Spain
        • Hospital Clinic De Barcelona
      • Barcelona, Spain
        • Hospital del Mar
      • Barcelona, Spain
        • Hospital De La Santa Creu I Sant Pau
      • Barcelona, Spain
        • Hospital Vall d'Hebron
      • Córdoba, Spain
        • Hospital Reina Sofia
      • Huelva, Spain
        • Hospital Juan Ramón Jimenez
      • Las Palmas De Gran Canaria, Spain
        • Hospital Doctor Negrín
      • León, Spain
        • Hospital Universitario de Leon
      • Lugo, Spain
        • Hospital Lucus Augusti
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain
        • Clinica Universidad de Navarra
      • Murcia, Spain
        • Hospital Virgen de la Arrixaca
      • Palma De Mallorca, Spain
        • Hospital Universitario Son Espases
      • Santander, Spain
        • Hospital Marques de Valdecilla
      • Santiago De Compostela, Spain
        • Hospital de Santiago
      • Tarragona, Spain
        • Hospital Joan XXIII
      • Tenerife, Spain
        • Hospital Universitario de Canarias
      • Toledo, Spain
        • Hospital Virgen de la Salud
      • Valencia, Spain
        • Hospital Clinico de Valencia
      • Vigo, Spain
        • Hospital Álvaro Cunqueiro
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital Universitari de Bellvitge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Amphilimus-eluting stents
Polymer-free Amphilimus-eluting stents
Device: Polymer-free amphilimus-eluting stents
Cre8 Evo coronary stent system (CID, Saluggia, Italy)
Active Comparator: Zotarolimus-eluting stents
Biolinx Polymer-based zotarolimus-eluting stents
Device: Biolinx Polymer-based zotarolimus-eluting stents
Resolute Onyx coronary stent system (Medtronic, Minneapolis, Minnesota, US)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target lesion failure at 1-year follow-up
Time Frame: 12 months
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
Time Frame: 24 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac death
Time Frame: 12 and 24 months
12 and 24 months
Target vessel myocardial infarction
Time Frame: 12 and 24 months
12 and 24 months
Target vessel revascularization
Time Frame: 12 and 24 months
12 and 24 months
Target lesion revascularization
Time Frame: 12 and 24 months
12 and 24 months
Stent thrombosis
Time Frame: 12 and 24 months
Academic Research Consortium definitions
12 and 24 months
Non-target lesion revascularization
Time Frame: 12 and 24 months
12 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spanish Society of Cardiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2017

Primary Completion (Anticipated)

January 28, 2021

Study Completion (Anticipated)

January 28, 2022

Study Registration Dates

First Submitted

October 22, 2017

First Submitted That Met QC Criteria

October 22, 2017

First Posted (Actual)

October 25, 2017

Study Record Updates

Last Update Posted (Actual)

January 19, 2021

Last Update Submitted That Met QC Criteria

January 14, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEC-SUG-2016-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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