Evaluating Safety and Effectiveness of Low-Dose Colchicine for Adults With Statin Intolerance to Lower Heart Risks

What this Trial Is About

Statin intolerance can increase the risk of cardiovascular events due to untreated high cholesterol and inflammation. This research aims to evaluate the safety and effectiveness of low-dose colchicine LODOCO, an anti-inflammatory drug approved by the FDA to reduce cardiac risks, in adults who cannot tolerate statins. The study focuses on people aged 18 to 80 with a history of statin intolerance and existing heart risk factors. Participants will be randomly assigned to receive either low-dose colchicine 0.5 mg once daily followed by a placebo for 4 weeks, or placebo followed by low-dose colchicine for 4 weeks, in a crossover design. The study includes careful monitoring of safety through adverse events and efficacy by measuring changes in inflammation markers like high-sensitivity C-reactive protein hs-CRP. Additional measures include changes in interleukin-6 and lipid profiles. Throughout the study, participants undergo regular assessments from baseline to four weeks, including blood tests to monitor inflammation and cholesterol levels. Researchers track side effects and overall safety during treatment periods. The total participation time is approximately eight weeks, covering both treatment phases and follow-up evaluations. This allows a detailed understanding of the drugs impact on inflammation and cardiovascular risk in statin-intolerant adults.

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