Ranolazine, Ethnicity and the Metabolic Syndrome (REMS)

Atlanta Heart Specialists, LLC

Status and phase: Unknown; Phase 4

Conditions: Coronary Artery Disease; Metabolic Syndrome; Angina

Treatments: Drug: Ranolazine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01304095

AHS-REMS-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Ranolazine

Active Comparator group

Description:

Ranolazine in addition to standard of care medical therapy

Treatment:

Drug: Ranolazine

Standard of Care

No Intervention group