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NCT03321032: SUGAR
Second-generation Drug-eluting Stents in Diabetes
Phase 4 trial testing Polymer-free amphilimus-eluting stents in Coronary Artery Disease in 1,164 participants. Status unknown.
28 January 2021
Quick facts
| Lead sponsor | Spanish Society of Cardiology |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 1,164 |
| Start date | 19 December 2017 |
| Primary completion | 28 January 2021 |
| Estimated completion | 28 January 2022 |
| Sites | 23 locations across Spain |
Drugs / interventions tested
- Polymer-free amphilimus-eluting stents
- Biolinx Polymer-based zotarolimus-eluting stents
Conditions studied
- Coronary Artery Disease — all drugs for Coronary Artery Disease →
- Diabetes Mellitus — all drugs for Diabetes Mellitus →
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):
-
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 -
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 -
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:
- PubMed search for NCT03321032
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Spanish Society of Cardiology trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03321032 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Spanish Society of Cardiology
- Last refreshed: 19 January 2021
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