Clinical trial NCT06874192: Safety and Efficacy of LOw DOse COlchicine in Patients With STatin INTolerance: the LODOCO STINT Pilot Study
Official title: Safety and Efficacy of LOw DOse COlchicine in Patients With STatin INTolerance: the LODOCO STINT Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Statin Adverse Reaction
Keywords: statin intolerance
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Single-center, double-blind, placebo-controlled, randomized cross-over pilot study
Primary purpose: TREATMENT

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 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.

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 objective of this study is to evaluate the safety and efficacy of low-dose colchicine (LODOCO) in subjects with statin intolerance. Safety will be assessed by monitoring the incidence of adverse events from baseline to four weeks. Efficacy will be determined by measuring the change in high-sensitivity C-reactive protein (hs-CRP) levels from baseline to four weeks..

Eligibility 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.

Primary outcomes:
measure: Safety will be assessed by monitoring the incidence of adverse events
timeFrame: Baseline to four weeks.
measure: Efficacy will be determined by measuring the change in high-sensitivity C-reactive protein
timeFrame: Baseline to four weeks
Secondary outcomes:
measure: To investigate the changes in interleukin-6 (IL-6) levels with low-dose colchicine therapy in patients with statin intolerance.
timeFrame: baseline to four weeks
measure: To assess changes in lipid profile from baseline to 30 days
timeFrame: baseline to four weeks.
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Anurag Mehta
role: PRINCIPAL_INVESTIGATOR
References: