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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
United States
Virginia
Virginia Commonwealth University
RECRUITING
Richmond
Contact Information
Primary
Emily Federmann
Emily.Federmann@vcuhealth.org
804-828-3299
Backup
Joshua West
Joshua.West@vcuhealth.org
804.628.3981
Time Frame
Start Date: 2025-03-12
Estimated Completion Date: 2026-04-01
Participants
Target number of participants: 30
Treatments
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)
Sponsors
Leads: Virginia Commonwealth University

This content was sourced from clinicaltrials.gov