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Safety and Efficacy of LOw DOse COlchicine in Patients With STatin INTolerance: the LODOCO STINT Pilot Study

RECRUITING
I'm interested

18 years to 80 years old
This study is NOT accepting healthy volunteers
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.

DRUG: Low-dose colchicine at 0.5mg daily, OTHER: Placebo

Statin Adverse Reaction

statin intolerance

Emily Federmann - Emily.Federmann@vcuhealth.org
PHASE1
NCT06874192

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