Ranolazine, Ethnicity and the Metabolic Syndrome

Phase 4

• Conditions: Coronary Artery Disease; Angina; Metabolic Syndrome
• Interventions: Drug: Ranolazine

• Registration Number: NCT01304095
• Lead Sponsor: Atlanta Heart Specialists, LLC

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-02-16
• Study First Submitted QC: 2011-02-24
• Study First Posted: 2011-02-25
• Status Verified: 2013-07
• Primary Completion: 2013-07
• Last Update Submitted: 2013-07-09
• Last Update Posted: 2013-07-11
• Study Completion: 2013-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ranolazine	Ranolazine	Ranolazine in addition to standard of care medical therapy

Primary Outcome Measures

Name	Time	Method
Exercise Duration	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.

Secondary Outcome Measures

Name	Time	Method
fasting glucose	change from baseline to 6 months	To measure the effect ranolazine has on fasting blood glucose.
Angina	change from baseline to 6 months	To look at the effect of ranolazine on anginal episodes using the Seattle Angina Questionnaire (SAQ).
Concomitant medications	change from baseline to 6 months	To measure the impact of ranolazine on reducing concomitant medication therapy such as anti-arrhythmic agents, hypoglycemic agents, and nitrates.
lipid profile	change from baseline to 6 months	To measure the effect ranolazine has on lipid profile.
HgbA1c	change from baseline to 6 months	To measure the effect ranolazine has on hemoglobin A1c.

Trial Locations

Locations (2)

Atlanta Heart Specialist, LLC; 🇺🇸 Cumming, Georgia, United States

Atlanta Heart Specialists, LLC; 🇺🇸 Tucker, Georgia, United States