Ranolazine, Ethnicity and the Metabolic Syndrome

• Status: Unknown status
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Atlanta Heart Specialists, LLC
• Collaborator: Gilead Sciences
• Treatments: Ranolazine

Criteria

Inclusion Criteria:

1. 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

2. 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)

3. Symptoms of angina or a suspected angina equivalent (upper body chest pain, shortness of breath, fatigue)

4. Patient able to perform an exercise treadmill test (ETT)

5. Written informed consent

6. Age > 18 years old

Exclusion Criteria:

• 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