Ranolazine, Ethnicity and the Metabolic Syndrome - REMS Study
试验速览
- 阶段
- 4 期
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Exercise Duration
研究概览
简要总结
The purpose of this study is to measure the effect of ranolazine on ETT (exercise treadmill test) exercise duration in four ethnic subgroups with established coronary artery disease and risk factor(s) for the metabolic syndrome: Caucasian, African American, Southeast Asian and East Indian.
详细描述
Studies have shown that various ethnic subgroups are at differential risk for both the development and progression of coronary artery disease. The East Indian population is one of the highest risk populations for coronary artery disease. Much of this increased risk is driven by the development and progression of diabetes.
Recent studies have shown that ranolazine has a favorable effect on glycemic control. In addition, it is an effective antianginal and antiarrhythmic agent.
The investigators propose a pilot study look at the safety, tolerability and efficacy of this agent in patients with established coronary artery disease (CAD) and risk factors for the metabolic syndrome from various ethnic backgrounds. In particular the investigators will focus on the Caucasian, African American, Southeast Asian and East Indian population.
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
- None
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
- •Evidence of stable Coronary Artery Disease
- •MI > 30 days prior to enrollment
- •PCI > 30 days prior to enrollment
- •CABG > 30 days prior to enrollment
- •Angiography showing > 50% stenosis in a major vessel, branch or bypass graft > 30 days prior to enrollment
- •Metabolic Syndrome as evidenced by at least one of the following risk factors:
- •Abdominal Obesity (elevated waist circumference)
- •Men - waist circumference ≥ 40 inches (102 cm) Asians/Asian Americans ≥ 35.5 inches (90 cm)
- •Women - waist circumference ≥ 35 inches (88 cm) Asians/Asian Americans ≥ 31.5 inches (80 cm)
- •Atherogenic dyslipidemia (either one or both)
- •Triglycerides ≥ 150 mg/dL
- •Reduced HDL Men - HDL ≤ 40 mg/dL Women - HDL ≤ 50 mg/dL
- •Elevated Blood Pressure (equal to or greater than 130/85)
- •Elevated fasting glucose (equal to or greater than 100 mg/dL)
- •Symptoms of angina or a suspected angina equivalent (upper body chest pain, shortness of breath, fatigue)
- •Patient able to perform an exercise treadmill test (ETT)
- •Written informed consent
- •Age > 18 years old
排除标准
- •Unstable coronary artery disease or revascularization within 30 days of enrollment.
- •Patients who have a prolonged QTc interval (>500ms)
- •Patients who have known severe liver disease
- •Current or planned co-administration of strong CYP3A inhibitors (eg, ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir) OR CYP3A inducers (eg, rifampin, rifabutin, rifapentine, Phenobarbital, phenytoin, carbamazepine, and St. John's Wort) OR moderate CYP3A inhibitors (eg, diltiazem, verapamil, aprepitant, erythromycin, fluconazole, and grapefruit juice or grapefruit-containing products)
- •Patients who are pregnant or lactating
- •Patients who are likely to be noncompliant with study procedures
- •Patients currently in a study, or within 30 days of participating in a study, of an investigational drug or device
研究组 & 干预措施
Ranolazine
Ranolazine in addition to standard of care medical therapy
干预措施: Ranolazine (Drug)
结局指标
主要结局
Exercise Duration
时间窗: change from baseline to 6 months
To measure the effect of ranolazine on ETT (exercise treadmill test) exercise duration in four ethnic subgroups with established coronary artery disease and risk factor(s) for the metabolic syndrome: Caucasian, African American, Southeast Asian and East Indian.
次要结局
- fasting glucose(change from baseline to 6 months)
- Angina(change from baseline to 6 months)
- Concomitant medications(change from baseline to 6 months)
- lipid profile(change from baseline to 6 months)
- HgbA1c(change from baseline to 6 months)
研究者
Narendra Singh, MD
Director, Clinical Research-AHS
Atlanta Heart Specialists, LLC