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Coronary Artery DiseasePhase 4SUGARNCT03321032

Second-generation Drug-eluting Stents in Diabetes

A Phase 4 study testing Polymer-free amphilimus-eluting stents and Biolinx Polymer-based zotarolimus-eluting stents in people with Coronary Artery Disease and Diabetes Mellitus, run by Spanish Society of Cardiology at 23 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Coronary Artery Disease, Diabetes Mellitus
What is being tested?
Polymer-free amphilimus-eluting stents and Biolinx Polymer-based zotarolimus-eluting stents
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,164 participants
Where
23 sitesSpain
Study dates
19 Dec 2017to 28 Jan 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

Spain23 sites

  • Hospital General Universitario de Alicante

    Alicante

  • Hospital San Juan

    Alicante

  • Hospital Clinic de Barcelona

    Barcelona

  • Hospital de la Santa Creu i Sant Pau

    Barcelona

  • Hospital del Mar

    Barcelona

  • Hospital Vall d'Hebrón

    Barcelona

  • Hospital Reina Sofía

    Córdoba

  • Hospital Juan Ramón Jiménez

    Huelva

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Doctor Negrín

    Las Palmas de Gran Canaria

  • Hospital Universitario de León

    León

  • Hospital Lucus Augusti

    Lugo

  • Hospital Clínico San Carlos

    Madrid, 28040

  • Clínica Universidad de Navarra

    Madrid

  • Hospital Virgen de la Arrixaca

    Murcia

  • Hospital Universitario Son Espases

    Palma de Mallorca

  • Hospital Universitario de Canarias

    Santa Cruz de Tenerife

  • Hospital Marqués de Valdecilla

    Santander

  • Hospital de Santiago

    Santiago de Compostela

  • Hospital Joan XXIII

    Tarragona

  • Hospital Virgen de la Salud

    Toledo

  • Hospital Clínico de Valencia

    Valencia

  • Hospital Álvaro Cunqueiro

    Vigo

Other trials in Spain

About this study

Official title: 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).

Being tested
Polymer-free amphilimus-eluting stents, Biolinx Polymer-based zotarolimus-eluting stents
Keywords
Coronary Artery Disease, Diabetes Mellitus, Drug-eluting stents, Restenosis
Medical subject headings
Coronary Artery Disease, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Polymer-free amphilimus-eluting stentsDevice

    Cre8 Evo coronary stent system (CID, Saluggia, Italy)

  • Biolinx Polymer-based zotarolimus-eluting stentsDevice

    Resolute Onyx coronary stent system (Medtronic, Minneapolis, Minnesota, US)

Study groups in NCT03321032
Study groupRoleWhat they receive
Amphilimus-eluting stentsExperimentalPolymer-free Amphilimus-eluting stents
Receives: Device: Polymer-free amphilimus-eluting stents
Zotarolimus-eluting stentsActive comparatorBiolinx Polymer-based zotarolimus-eluting stents
Receives: Device: Biolinx Polymer-based zotarolimus-eluting stents

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months

  2. 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.

    Measured: 24 months

Secondary outcomes (6)

  1. Cardiac death

    Measured: 12 and 24 months

  2. Target vessel myocardial infarction

    Measured: 12 and 24 months

  3. Target vessel revascularization

    Measured: 12 and 24 months

  4. Target lesion revascularization

    Measured: 12 and 24 months

  5. Stent thrombosis

    Academic Research Consortium definitions

    Measured: 12 and 24 months

  6. Non-target lesion revascularization

    Measured: 12 and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2017
  2. Study start19 Dec 2017
  3. Primary completion28 Jan 2021 (estimated)
  4. Study completion28 Jan 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
1,164 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03321032
Sponsor's protocol ID
SEC-SUG-2016-01
Acronym
SUGAR
Status last verified
Jan 2021
First submitted
22 Oct 2017
Last updated
19 Jan 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 32087418

  • Salinas 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.

    PubMed 40562528

  • 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.

    PubMed 34735004

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Polymer-free amphilimus-eluting stents and Biolinx Polymer-based zotarolimus-eluting stents in people with Coronary Artery Disease and Diabetes Mellitus, run by Spanish Society of Cardiology at 23 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target lesion failure at 1-year follow-up (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03321032, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2021; AzTrials last refreshed its copy on 1 Nov 2026.

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