Last reviewed · How we verify

NCT03321032: SUGAR

Second-generation Drug-eluting Stents in Diabetes

Status unknown Phase 4 Last updated 19 January 2021
What this trial tests

Phase 4 trial testing Polymer-free amphilimus-eluting stents in Coronary Artery Disease in 1,164 participants. Status unknown.

Timeline
19 December 2017
Primary endpoint
28 January 2021
28 January 2022

Quick facts

Lead sponsorSpanish Society of Cardiology
PhasePhase 4
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment1,164
Start date19 December 2017
Primary completion28 January 2021
Estimated completion28 January 2022
Sites23 locations across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Spanish Society of Cardiology

Who can join

Adults 18 to 100, any sex, with Coronary Artery Disease or Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Amphilimus- vs. zotarolimus-eluting stents in patients with diabetes mellitus and coronary artery disease: the SUGAR trial.
    Romaguera R, Salinas P, Gomez-Lara J, Brugaletta S, et al · · 2022 · cited 30× · PMID 34735004 · DOI 10.1093/eurheartj/ehab790
  2. Comparison of Contemporary Drug-eluting Coronary Stents - Is Any Stent Better than the Others?
    Parker W, Iqbal J. · · 2020 · cited 12× · PMID 36277668 · DOI 10.17925/hi.2020.14.1.34
  3. Amphilimus-eluting versus zotarolimus-eluting stents in patients with diabetes mellitus and coronary artery disease: extended follow-up of the SUGAR randomised controlled trial.
    Salinas P, Romaguera R, Gómez-Lara J, Brugaletta S, et al · · 2025 · cited 1× · PMID 40562528 · DOI 10.1136/heartjnl-2025-325773

Verify or expand the search:

Other recruiting trials for Coronary Artery Disease

Currently open trials in the same condition.

Other Spanish Society of Cardiology trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03321032.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing