Status:
RECRUITING
Safety and Efficacy of LOw DOse COlchicine in Patients With STatin INTolerance: the LODOCO STINT Pilot Study
Lead Sponsor:
Virginia Commonwealth University
Conditions:
Statin Adverse Reaction
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief 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 cholestero...
Detailed Description
This study will test the effects of LODOCO in those who have previously been identified as statin intolerant, meaning they are unable to continue taking statins because of side effects. The primary ob...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06874192
Start Date
March 12 2025
End Date
April 1 2026
Last Update
May 15 2025
Active Locations (1)
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1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298