Randomized Trial of the Association Between Low-Dose Statins and Nutraceuticals in High-intEnsity Statin-intoleRant patiENts With Very High Risk Coronary Artery diseasE
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Long-term adherence to study treatments
研究概览
简要总结
The primary objective of this study is to compare the efficacy and tolerability of low-dose statin therapy vs. the association between a low-dose statin and a nutraceutical-based protocol in high-dose statin-intolerant patients with coronary artery disease deemed to be at high-risk.
详细描述
Several clinical trials have shown that in patients with atherosclerotic cardiovascular disease, reduction of low-density lipoprotein (LDL) level with a beta-hydroxy-beta-methylglutaryl coenzyme A reductase inhibitor (ie, statin) is associated with significant reductions in both mortality rate and major cardiac events.
Accordingly, current guidelines recommend that high-intensity statin therapy-such as rosuvastatin 20 to 40 mg or atorvastatin 80 mg-should be used to achieve at least a 50% reduction in LDL cholesterol unless otherwise contraindicated.
In real world clinical practice, however, high-intensity statin treatment is often discontinued by patients due to side effects. As alternatives, nonstatin drugs, such as ezetimibe, are often prescribed in association with moderate-to-low intensity statin.
It remains unknown, however, whether the association between moderate-to-low intensity statin therapy and and nutraceuticals (i.e. compounds derived from foods with cholesterol lowering actions) can have a therapeutic role in high-intensity statin-intolerant patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Angiographically-proven coronary artery disease
- •Recent (<12 months) percutaneous coronary intervention
- •Class I indication to receive statin treatment to achieve the LDL cholesterol goal of <70 mg/dL
- •Able to understand and willing to sign the informed consent form
排除标准
- •Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT
研究组 & 干预措施
Association low-dose statin and nutraceuticals
Patients will receive the association between low-dose statin (10 to 20 mg/day of simvastatin or 5 to 10 mg/day atorvastatin) and a commercially available nutraceutical combined pill (1 capsule/day containing red yeast rice 200 mg, policosanol 10 mg, and berberine 500 mg).
干预措施: Association low-dose statin and nutraceuticals (Drug)
Low-dose statin
Patients will receive low-dose statin (10 to 20 mg/day of simvastatin or 5 to 10 mg/day atorvastatin)
干预措施: Association low-dose statin and nutraceuticals (Drug)
结局指标
主要结局
Long-term adherence to study treatments
时间窗: Up to 12 months
Satisfactory compliance (≥80%) in taking study drugs
次要结局
- Number of participants with target LDL cholesterol(Up to 12 months)
研究者
Francesco Pelliccia
Assistant Professor
University of Roma La Sapienza