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

NCT05250596 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2024-07-16

No results posted yet for this study

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.

Conditions

  • Non ST Segment Elevation Acute Coronary Syndrome

Interventions

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.

Sponsors & Collaborators

  • Azienda USL Toscana Centro

    lead OTHER

Principal Investigators

  • Anna Toso, MD · Santo Stefano Hospital, Prato, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-24
Primary Completion
2024-02-24
Completion
2024-05-30

Countries

  • Italy

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05250596 on ClinicalTrials.gov