Actively Recruiting
Safety and Efficacy of LOw DOse COlchicine in Patients With STatin INTolerance: the LODOCO STINT Pilot Study
Led by Virginia Commonwealth University · Updated on 2026-04-13
30
Participants Needed
1
Research Sites
63 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Safety and Efficacy of LOw DOse COlchicine in Patients With STatin INTolerance: the LODOCO STINT Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- History of statin intolerance as defined by NLA 2023 guidelines, with one or more side effects from statins that improve or resolve with dose change
- Stable dose of lipid-lowering treatment (statin or non-statin) for at least one month
- Able to provide informed consent
- Aged between 18 and 80 years
You will not qualify if you...
- Known allergy to colchicine or current use of colchicine or other anti-inflammatory drugs
- Kidney impairment with eGFR below 45 mL/min/1.73 m2
- Elevated liver enzymes (ALT or AST more than 3 times normal)
- Cirrhosis
- Severe heart failure
- Active cancer or undergoing chemotherapy
- Irritable Bowel Syndrome, Inflammatory Bowel Disease, or other diarrhea-related gut conditions
- Active infection
- Autoimmune or inflammatory diseases
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
Research Team
E
Emily Federmann
CONTACT
J
Joshua West
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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