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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03321032
Recruitment Status : Unknown
Verified January 2021 by Dr Rafael Romaguera, Spanish Society of Cardiology.
Recruitment status was:  Active, not recruiting
First Posted : October 25, 2017
Last Update Posted : January 19, 2021
Sponsor:
Information provided by (Responsible Party):
Dr Rafael Romaguera, Spanish Society of Cardiology

Study Description
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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).


Condition or disease Intervention/treatment Phase
Coronary Artery Disease Diabetes Mellitus Device: Polymer-free amphilimus-eluting stents Device: Biolinx Polymer-based zotarolimus-eluting stents Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Second-generation drUg-elutinG Stents in diAbetes: a Randomized Trial (the SUGAR Trial)
Actual Study Start Date : December 19, 2017
Estimated Primary Completion Date : January 28, 2021
Estimated Study Completion Date : January 28, 2022
Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Cardiac death [ Time Frame: 12 and 24 months ]
  2. Target vessel myocardial infarction [ Time Frame: 12 and 24 months ]
  3. Target vessel revascularization [ Time Frame: 12 and 24 months ]
  4. Target lesion revascularization [ Time Frame: 12 and 24 months ]
  5. Stent thrombosis [ Time Frame: 12 and 24 months ]
    Academic Research Consortium definitions

  6. Non-target lesion revascularization [ Time Frame: 12 and 24 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03321032


Locations
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Sponsors and Collaborators
Spanish Society of Cardiology
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr Rafael Romaguera, Principal Investigator, Spanish Society of Cardiology
ClinicalTrials.gov Identifier: NCT03321032    
Other Study ID Numbers: SEC-SUG-2016-01
First Posted: October 25, 2017    Key Record Dates
Last Update Posted: January 19, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Rafael Romaguera, Spanish Society of Cardiology:
Coronary Artery Disease
Diabetes Mellitus
Drug-eluting stents
Restenosis
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases