Safety and Efficacy of LOw DOse COlchicine in Patients With STatin INTolerance: the LODOCO STINT Pilot Study
Purpose
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.
Condition
- Statin Adverse Reaction
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Intervention Model Description
- Single-center, double-blind, placebo-controlled, randomized cross-over pilot study
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
- Masking Description
- Participants will be randomized in a 1:1 ratio to receive either low-dose colchicine (0.5 mg once daily) or matching placebo for 4 weeks.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Low dose colchicine and then matching placebo |
Participants in this arm will be randomized to receive low-dose colchicine (0.5 mg once daily) and then placebo for 4 weeks |
|
|
Experimental Matching placebo and then low dose colchicine |
Participants in this arm will be randomized to receive placebo for 4 weeks and then low-dose colchicine (0.5 mg once daily) |
|
Recruiting Locations
Richmond, Virginia 23298
More Details
- NCT ID
- NCT06874192
- Status
- Recruiting
- Sponsor
- Virginia Commonwealth University
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..