Improvement of Subjective Well-Being by Ranolazine Among Unrevascularized Chronic Stable Coronary Artery Disease Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Seattle Angina Questionnaire Score Change From Baseline to 16 Weeks
研究概览
简要总结
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 stable coronary artery disease patients who have demonstrable myocardial ischemia, but who do not undergo revascularization
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 stable coronary artery disease patients who have demonstrable myocardial ischemia, but who do not undergo revascularization.
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
- Single Group
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult 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
- •QTc > 500 milliseconds
- •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 insufficiency (i.e. creatinine clearance < 30mL/min/1.73 m2)
研究组 & 干预措施
Ranolazine
Ranolazine 500 mg tablets
- 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 16 Weeks
时间窗: Change in baseline to 16 weeks
The SAQ quantifies patients' physical limitations caused by angina, the frequency of and recent changes in their symptoms, their satisfaction with treatment, and the degree to which they perceive their disease to affect their quality of life.Each of the 5 dimensions are scored by assigning eachresponse an ordinal value, beginning with 1 for the response that implies the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range1 / 3 Seattle Angina Questionnaire (SAQ)of the scale and multiplying by 100. No overall scale score is generated. Factors and Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life). .
次要结局
- Subjective Well Being(Compare from baseline to month 4)
- Ischemia Driven Revascularization or Hospitalization(4 month)
研究者
Anthony A Bavry
Interventional Cardiologist
North Florida Foundation for Research and Education