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NCT05250596: COLOR-ACS
COLchicine On-admission to Reduce Inflammation in Acute Coronary Syndrome (COLOR-ACS)
Phase 2 trial testing Colchicine in Non ST Segment Elevation Acute Coronary Syndrome in 182 participants. Completed in 30 May 2024.
24 February 2024
Quick facts
| Lead sponsor | Azienda USL Toscana Centro |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 182 |
| Start date | 24 February 2022 |
| Primary completion | 24 February 2024 |
| Estimated completion | 30 May 2024 |
| Sites | 3 locations across Italy |
Drugs / interventions tested
- Colchicine (COLCHICINE) — full drug profile →
- Atorvastatin (atorvastatin) — full drug profile →
Conditions studied
- Non ST Segment Elevation Acute Coronary Syndrome — all drugs for Non ST Segment Elevation Acute Coronary Syndrome →
Sponsor
Azienda USL Toscana Centro
Who can join
18 and older, any sex, with Non ST Segment Elevation Acute Coronary Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Since colchicine is known to have anti-inflammatory effects and inflammation is an early component of acute coronary syndrome (ACS), this study aims to evaluate the acute effects of low-dose colchicine, in addition to atorvastatin, administered on-admission to statin-naive patients with non-ST elevation ACS scheduled for early invasive strategy.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Molecular and Immunomodulatory Mechanisms of Statins in Inflammation and Cancer Therapeutics with Emphasis on the NF-κB, NLRP3 Inflammasome, and Cytokine Regulatory Axes.
Khan S, Huda B, Bhurka F, Patnaik R, et al · · 2025 · cited 7× · PMID 40943351 · DOI 10.3390/ijms26178429 -
Rationale and design of COLchicine On-admission to Reduce inflammation in Acute Coronary Syndrome (COLOR-ACS) study.
Toso A, Leoncini M, Magnaghi G, Biagini F, et al · · 2023 · cited 2× · PMID 36473121 · DOI 10.2459/jcm.0000000000001389 -
Anti-inflammatory therapy in atherosclerotic cardiovascular disease: Current reappraisal.
Muduli S, Gupta MD, Mp G, Yadav R. · · 2023 · cited 1× · PMID 37890557 · DOI 10.1016/j.ihj.2023.10.007
Verify or expand the search:
- PubMed search for NCT05250596
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT06578182 — The Effect of ColcHicine on the Incidence of Knee or Hip Replacements · Phase 3 · recruiting
- NCT06203977 — Inflammation REduction to Prevent cArdiovascular Injury in Renal Disease (REPAIR) · Phase 1 · recruiting
Other recruiting trials for Non ST Segment Elevation Acute Coronary Syndrome
Currently open trials in the same condition.
- NCT06695429 — Supplementation With Beetroot Juice to Prevent Contrast Associated Nephropathy During Hospitalization for Acute Coronary · NA · recruiting
- NCT06197724 — MCG for Identification of Myocardial Ischemia in Suspected NSTE-ACS Patients · recruiting
- NCT06255678 — Angio-based Final Functional Effect of PCI · recruiting
- NCT05117866 — Acetyl Salicylic Elimination Trial JAPAN: The ASET JAPAN Pilot Study · NA · active not recruiting
Other Azienda USL Toscana Centro trials
Trials by the same sponsor.
- NCT06863896 — Laparoscopic Hartmann's Reversal Procedure: In the Absence of Standardized Guidelines, we Started a Database of Patient · not yet recruiting
- NCT04141410 — Global Longitudinal Strain Assessment in Cardiogenic Shock During Sepsis · unknown
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 NCT05250596 (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 Azienda USL Toscana Centro
- Last refreshed: 16 July 2024
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/NCT05250596.
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