Testing low-dose colchicine for patients who can't tolerate statins
Safety and Efficacy of LOw DOse COlchicine in Patients With STatin INTolerance: the LODOCO STINT Pilot Study
This study is testing if low-dose colchicine can help people who can't take statins lower their cholesterol and reduce inflammation safely.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Virginia Commonwealth University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Richmond, Virginia) |
| Trial ID | NCT06874192 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the safety and efficacy of low-dose colchicine in patients who have been identified as intolerant to statins due to adverse reactions. The study aims to determine whether colchicine can effectively reduce inflammation and improve cholesterol levels in these patients, thereby lowering their risk of cardiovascular events. Participants will receive either low-dose colchicine or a placebo for four weeks, with safety monitored through adverse event reporting and efficacy assessed by changes in high-sensitivity C-reactive protein levels.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with a documented history of statin intolerance.
Not a fit: Patients with known hypersensitivity to colchicine, severe renal impairment, or active inflammatory conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide an alternative for patients who cannot tolerate statins, potentially reducing their risk of cardiovascular events.
How similar studies have performed: Previous studies have shown promise in using colchicine for cardiovascular protection, suggesting this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * History of statin intolerance (As defined by the NLA 2023 guidelines) Patients who have experienced one or more adverse effects associated with statin therapy, which resolves or improves with dose continuation or reduction * Stable dose of lipid-lowering regimen (statin or non-statin) for at least one month * Patients able to provide informed consent. * Aged 18 to 80 will be enrolled in the study. Exclusion Criteria: * Known hypersensitivity to colchicine, current use of colchicine or other anti-inflammatory medications. * Renal impairment (eGFR \<45 mL/min/1.73 m2) * Transaminitis (ALT or AST \>3 times upper limit of normal) * Cirrhosis * Severe Heart Failure * Active cancer or currently on chemotherapy * Irritable Bowel Syndrome, Inflammatory Bowel Disease (Crohn's or Ulcerative Colitis) or other diarrheal related GI pathologies * Active infection * Autoimmune or inflammatory condition * Pregnancy or breastfeeding.
Where this trial is running
Richmond, Virginia
- Virginia Commonwealth University — Richmond, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Anurag Mehta — Virginia Commonwealth University
- Study coordinator: Emily Federmann
- Email: Emily.Federmann@vcuhealth.org
- Phone: 804-828-3299
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.