Randomized Trial of Ezetimibe Versus nutraCeuticals in Statin-intoLerant patIents Treated With PercutaneouS Coronary Intervention
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
- Evaluation of treatment tolerability
研究概览
简要总结
Pharmacologic alternatives in statin-intolerant patients include ezetimibe and nutraceuticals (i.e. compounds derived from foods with cholesterol lowering actions). The investigators will compare the efficacy and tolerability of ezetimibe versus a nutraceutical-based protocol in statin-intolerant patients treated with percutaneous coronary intervention.
详细描述
Background
Treatment with statins has a class I indication after percutaneous coronary intervention (PCI), but is often discontinued by patients due to side effects.
Pharmacologic alternatives shown to be useful after PCI include ezetimibe and nutraceuticals (i.e. compounds derived from foods with cholesterol lowering actions).
It remains unknown, however, which of these two therapeutic approaches is more effective after PCI.
Purpose
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
- 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
- •Previous (< 12 months) withdrawn of a statin due to side effects
- •Unwilling to receive treatment with an alternative statin
- •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
研究组 & 干预措施
Ezetimibe
Patients assigned to ezetimibe will receive for 1 year ezetimibe (10 mg/day)
干预措施: Ezetimibe (Drug)
Nutraceuticals
Patients assigned to nutraceuticals will receive for 1 year 1 capsule/day containing red yeast rice 200 mg, policosanol 10 mg, and berberine 500 mg
干预措施: Nutraceuticals (Drug)
结局指标
主要结局
Evaluation of treatment tolerability
时间窗: Up to 12 months
Reasons for treatment discontinuation
次要结局
- Evaluation of drug effects on lipid and metabolic features(Up to 12 months)
研究者
Francesco Pelliccia
Assistant Professor
University of Roma La Sapienza