MedTrace Logo

Safety and Efficacy of LOw DOse COlchicine in Patients With STatin INTolerance: the LODOCO STINT Pilot Study

NCT06874192 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-04-13

No results posted yet for this study

Summary

Statins are a class of cholesterol lowering medications that contribute to reducing a person's risk of experiencing a cardiovascular event like heart attack. Along with the ability to lower cholesterol, statins also possess anti-inflammatory properties which contribute to their cardioprotective effects. Some people experience side effects while taking statins and are unable to continue treatment with them,which can then increase a person's risk of having cardiovascular issues due to untreated high cholesterol levels. Prior studies have shown that inflammation in the body may lead to an increased risk of a future cardiovascular events. Low dose colchicine (LODOCO), an anti-inflammatory agent, has been shown to reduce cardiovascular events by inhibiting inflammation, a major cause of cardiovascular disease. The United States Food and Drug Administration (FDA) has approved LODOCO to reduce the risk of a future cardiac events for those who have existing heart disease or possess multiple risk factors for heart disease.

Conditions

  • Statin Adverse Reaction

Interventions

DRUG

Low-dose colchicine at 0.5mg daily

LODOCO is low-dose colchicine at 0.5mg daily, ii is an FDA approved anti-inflammatory drug, to prevent cardiovascular events in patients with coronary artery disease. LODOCO works by inhibiting microtubule formation and reducing the activity of neutrophils, which play a key role in inflammation.

OTHER

Placebo

Matching placebo

Sponsors & Collaborators

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Anurag Mehta · Virginia Commonwealth University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-12
Primary Completion
2026-05-30
Completion
2026-05-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT06874192 on ClinicalTrials.gov