Safety and Efficacy of LOw DOse COlchicine in Patients With STatin INTolerance: the LODOCO STINT Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Safety will be assessed by monitoring the incidence of adverse events
研究概览
简要总结
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.
详细描述
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..
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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)
干预措施: Low-dose colchicine at 0.5mg daily (Drug)
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)
干预措施: Placebo (Other)
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
干预措施: Placebo (Other)
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
干预措施: Low-dose colchicine at 0.5mg daily (Drug)
结局指标
主要结局
Safety will be assessed by monitoring the incidence of adverse events
时间窗: Baseline to four weeks.
Safety will be assessed by monitoring the incidence of adverse events from baseline to four weeks. Adverse events and tolerability will be evaluated using investigator-administered questionnaires at scheduled study visits. Participants will be asked to self-report any symptoms between visits, and all adverse events will be documented.
Efficacy will be determined by measuring the change in high-sensitivity C-reactive protein
时间窗: 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. The measurement of hs-CRP pre and post treatment will assess the change in hs-CRP with colchicine. This will test the hypothesis that LODOCO through the inhibition of the inflammatory pathways will lead to a decrease in hs-CRP levels.
次要结局
- To investigate the changes in interleukin-6 (IL-6) levels with low-dose colchicine therapy in patients with statin intolerance.(baseline to four weeks)
- To assess changes in lipid profile from baseline to 30 days(baseline to four weeks.)