RecruitingPhase 1NCT06874192

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


Sponsor

Virginia Commonwealth University

Enrollment

30 participants

Start Date

Mar 12, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Low-dose colchicine at 0.5mg daily and Placebo for people with statin adverse reaction. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLow-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.

OTHERPlacebo

Matching placebo


Locations(1)

Virginia Commonwealth University

Richmond, Virginia, United States

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NCT06874192


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