TWice overnIght High-dose ranoLazIne Pretreatment for preventinG Myocardial iscHemic Damage in Patients With Stable Angina Undergoing 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
- Frequency of PCI-induced myocardial infarction
研究概览
简要总结
It has previously been shown that pretreatment with ranolazine 1,000 mg twice daily for 7 days can significantly reduce procedural myocardial injury in elective percutaneous coronary intervention (PCI). The investigators tested the hypothesis that twice overnight high-dose ranolazine loading before PCI can reduce the peri-procedural myocardial ischemic damage similarly to long-term pre-treatment with standard doses.
详细描述
Background
Ranolazine is a novel antianginal drug that reduces intracellular sodium and calcium accumulation during ischemia thus limiting ischemic injury.
It has previously been shown that pretreatment with ranolazine 1,000 mg twice daily for 7 days can significantly reduce procedural myocardial injury in elective percutaneous coronary intervention.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Angiographically-proven coronary artery disease
- •Class I indication to elective percutaneous coronary intervention
- •Stable conditions
- •No recent acute coronary syndromes
- •Normal baseline values of markers of myocardial damage (creatine kinase, creatine kinase-MB, myoglobin, and troponin I)
- •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
Ranolazine
Administration of two preprocedural doses of Ranolazine 12 hours apart (1,000 mg the night before PCI and 1,000 mg prior to PCI)
干预措施: Ranolazine (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Frequency of PCI-induced myocardial infarction
时间窗: Up to 48 hours after PCI
Occurrence of peri-procedural myocardial infarction (i.e. creatine kinase-MB\>3 times the upper reference limit)
次要结局
- Assessment of post-PCI peak values of markers of myocardial damage(Baseline and 48 hours after PCI)
- Rate of 30-day MACE(Up to 30 days after PCI)
研究者
Francesco Pelliccia
Assistant Professor
University of Roma La Sapienza