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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of low-dose colchicine (LODOCO), an anti-inflammatory medication, in people who cannot tolerate statins due to side effects. Statins are cholesterol-lowering drugs that help reduce the risk of heart problems, but some patients must stop using them, increasing their cardiovascular risk. This study focuses on whether LODOCO can help reduce inflammation, a key factor in heart disease, in statin-intolerant patients. Participants will be randomly assigned to receive either low-dose colchicine (0.5 mg once daily) followed by a placebo for four weeks, or a placebo followed by low-dose colchicine for four weeks. This crossover design allows researchers to compare the effects of colchicine against placebo within the same participants. LODOCO is FDA approved for reducing cardiac event risk in people with heart disease or multiple risk factors. During the study, participants will be monitored for side effects and changes in inflammatory markers, including high-sensitivity C-reactive protein and interleukin-6 levels, over four weeks. Researchers will also assess lipid profiles from baseline to 30 days. Safety is measured by tracking adverse events, and efficacy by changes in inflammation. The study is conducted by Virginia Commonwealth University and lasts about one month per treatment phase.
CONDITIONS
Brief 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 adverse effects that improve with dose change
- Stable dose of lipid-lowering treatment for at least one month
- Able to provide informed consent
- Aged 18 to 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 less than 45 mL/min/1.73 m2
- Elevated liver enzymes (ALT or AST more than 3 times upper normal limit)
- Cirrhosis
- Severe heart failure
- Active cancer or undergoing chemotherapy
- Irritable bowel syndrome, inflammatory bowel disease, or other diarrheal gastrointestinal 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 4 weeks per treatment period
Participants receive low-dose colchicine or placebo in a crossover design to evaluate safety and efficacy.
1 baseline visit and 1 follow-up visit per treatment period
Trial Site Locations
Total: 1 location
1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
Research Team
E
Emily Federmann
J
Joshua West
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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