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NCT03962686
Molecular Mechanisms and Carotid Atherosclerosis
trial testing statin Oral Tablet plus PCSK9i in Diabetes Mellitus, Type 2 in 76 participants. Completed in 1 January 2018.
1 January 2017
Quick facts
| Lead sponsor | University of Campania Luigi Vanvitelli |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 76 |
| Start date | 1 January 2015 |
| Primary completion | 1 January 2017 |
| Estimated completion | 1 January 2018 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- statin Oral Tablet plus PCSK9i — full drug profile →
Conditions studied
- Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
- Atherosclerosis of Artery — all drugs for Atherosclerosis of Artery →
- Atherosclerotic Plaque — all drugs for Atherosclerotic Plaque →
Sponsor
University of Campania Luigi Vanvitelli
Who can join
Adults 18 to 75, any sex, with Diabetes Mellitus, Type 2 or Atherosclerosis of Artery. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The role of methylase system and Proprotein convertase subtilisin/kexin type 9 (PCSK9) in the accelerated atherosclerotic progression of diabetic patients is unclear. Authors will evaluate methylase activity and PCSK9 in carotid plaques of asymptomatic diabetic and non diabetic patients, as well as the effect of statin added to PCSK9 inhibitors (PCSK9i) therapy vs. statin alone in diabetic plaques. Plaques will be obtained from 43 type 2 diabetic and 30 non diabetic patients undergoing carotid endarterectomy. Diabetic patients will receive statin therapy (n 23) or statin plus PCSK9i (140 mg of evolocumab; n 20) or placebo (n 23) for 4 months before scheduled endarterectomy. Plaques will be analyzed for macrophages (CD68), T-cells (CD3), inflammatory cells (HLADR), methylase activity, nuclear factor (NF)-KB, tumor necrosis factor (TNF)-alpha, nitrotyrosine, matrix metalloproteinase (MMP) and collagen content (immunohistochemistry and enzyme- linked immunosorbent assay. Authors' study hypothesis is that methylase and PCSK9 over-activity will be associated with enhanced inflammatory reaction and NF-KB expression in diabetic plaques. Secondly, the inhibition of methylase activity in atherosclerotic lesions of diabetic patients by metformin plus SLGT2i might be associated with morphological and compositional characteristics of a potential stable plaque phenotype, possibly by down regulating NF-KB-mediated inflammatory pathways.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Sodium-glucose co-transporter2 expression and inflammatory activity in diabetic atherosclerotic plaques: Effects of sodium-glucose co-transporter2 inhibitor treatment.
D'Onofrio N, Sardu C, Trotta MC, Scisciola L, et al · · 2021 · cited 87× · PMID 34500107 · DOI 10.1016/j.molmet.2021.101337 -
Endothelial mechanobiology in atherosclerosis.
Wang X, Shen Y, Shang M, Liu X, et al · · 2023 · cited 79× · PMID 37163659 · DOI 10.1093/cvr/cvad076 -
Advances and challenges of targeting epicardial adipose tissue (EAT) and perivascular adipose tissue (PVAT).
Liu D, Chen W, Guo Z, Gao Q, et al · · 2025 · cited 1× · PMID 40760703 · DOI 10.1186/s12933-025-02763-z
Verify or expand the search:
- PubMed search for NCT03962686
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University of Campania Luigi Vanvitelli 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 NCT03962686 (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 University of Campania Luigi Vanvitelli
- Last refreshed: 3 August 2022
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/NCT03962686.
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