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Safety and Efficacy of LOw DOse COlchicine in Patients With STatin INTolerance: the LODOCO STINT Pilot Study
Sponsor: Virginia Commonwealth University
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.
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2025-03-12
Completion Date
2026-04-01
Last Updated
2025-05-15
Healthy Volunteers
No
Conditions
Interventions
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.
Placebo
Matching placebo
Locations (1)
Virginia Commonwealth University
Richmond, Virginia, United States