Effect of Ranolazine After Deferral of Percutaneous Coronary Intervention by Fractional Flow Reserve (IMWELL3)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Seattle Angina Questionnaire Score Change From Baseline to Month 4
研究概览
简要总结
To determine if ranolazine improves angina symptoms at 4 months compared with placebo among patients who are deferred for receiving a Percutaneous Coronary Intervention (PCI) based on the Fractional Flow Reserve (FFR) measurement.
详细描述
This is a prospective, double-blind, placebo-controlled, randomized, single-center (North Florida- South Georgia VA Medical Center) study. The study objective is to determine if ranolazine improves angina symptoms at 4 months compared with placebo among patients who are deferred from having a PCI based on the FFR measurement.
Baseline Procedure:
Assessments performed exclusively to determine eligibility for this study would be done only after obtaining informed consent. Assessments performed for clinical indications (not exclusively to determine study eligibility) may be used for baseline values even if the studies were done before informed consent was obtained. The assessment will include:
- Informed Consent
- Review subject eligibility criteria
- FFR value calculated at the time of cardiac catheterization
- Review previous and concomitant medications
- Frequency of symptoms and quality of life prior to study according to Seattle Angina Questionnaire (SAQ)
Screening Visit:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable patients >= 18 years of age referred for cardiac catheterization for evaluation of cardiac symptoms ( angina, fatigue, or shortness of breath)
- •At least 1 indeterminate stenosis (20-80%), fractional flow reserve (FFR) >=0.8 and PCI deferred
排除标准
- •Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) during the index procedure or anticipated within the next month
- •acute coronary syndrome or cardiogenic shock
- •use of strong inhibitors of CTP3A (i.e. ketoconazole, itraconazole, clarithromycin,nefazodone, nelfinavir, ritonavir, indinavir and saquinavir)
- •use of inducers of CYP3A (i.e. rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, and St. John's wort)
- •liver cirrhosis
- •sever renal insufficience (i.e. creatinine clearance < 30mL/min/1.73 m2)
- •QTc > 500 milliseconds
研究组 & 干预措施
Ranolazine
Ranolazine 500mg tablet
- 500mg tablet two times per day for 7 days then,
- 500mg tablet (1000mg) two times per day for 15 weeks
干预措施: Ranolazine (Drug)
Sugar pill
Sugar pill that looks like the drug ranolazine 500mg tablet
- 500mg tablet two times per day for 7 days then,
- 500mg tablet (1000mg) two times per day for 15 weeks
干预措施: Sugar pill (Drug)
结局指标
主要结局
Seattle Angina Questionnaire Score Change From Baseline to Month 4
时间窗: Change in baseline to month 4
The Seattle Angina Questionnaire is a valid and reliable instrument that measures five clinically important dimensions of health in patients with coronary artery disease (physical limitation, anginal stability, anginal frequency, treatment satisfaction, and disease perception).
次要结局
- Ischemia Driven Revascularization or Hospitalization(4 month)
- Subjective Well Being(Compare from baseline to month 4)