NCT05250596

COLchicine On-admission to Reduce Inflammation in Acute Coronary Syndrome (COLOR-ACS)

On-admission Low-dose Colchicine in Addition to Atorvastatin to Reduce Inflammation in Acute Coronary Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 182 (actual)
• Sponsor: Azienda USL Toscana Centro · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

On-admission all statin naive NSTEACS patients are randomized to receive either standard treatment of atorvastatin 80 mg or standard treatment plus colchicine (1 mg loading dose followed by 0.5 mg/day). Inflammatory biomarker high sensitivity C reactive protein (hs-CRP) is measured in all patients on-admission and every 24 hours thereafter until discharge. Cardiac and renal function parameters are evaluated to evidence the possible beneficial effects of the administration of colchicine in addition to atorvastatin alone both short- and medium-term (up to 30 days). Colchicine tolerance is also investigated through monitoring for clinical side effects.

Conditions

• Non ST Segment Elevation Acute Coronary Syndrome

Interventions

Type	Name	Description
DRUG	Colchicine	Colchicine 1 mg (0.5 mg for patients ≤ 70 Kg) on-admission followed by 0.5 mg/day until discharge.
DRUG	Atorvastatin	Atorvastatin 80 mg on admission followed by 80 mg/day until discharge.

Timeline

• Start date: 2022-02-24
• Primary completion: 2024-02-24
• Completion: 2024-05-30
• First posted: 2022-02-22
• Last updated: 2024-07-16

Locations

3 sites across 1 country: Italy