Clinical trial NCT01304095: Ranolazine, Ethnicity and the Metabolic Syndrome
Official title: Ranolazine, Ethnicity and the Metabolic Syndrome - REMS Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Angina
Metabolic Syndrome
Keywords: Coronary Artery Disease, Angina, Metabolic Syndrome
Lead sponsor: Atlanta Heart Specialists, LLC
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2011-02-25
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Exercise Duration
timeFrame: change from baseline to 6 months
Secondary outcomes:
measure: fasting glucose
timeFrame: change from baseline to 6 months
measure: Angina
timeFrame: change from baseline to 6 months
measure: Concomitant medications
timeFrame: change from baseline to 6 months
measure: lipid profile
timeFrame: change from baseline to 6 months
measure: HgbA1c
timeFrame: change from baseline to 6 months
Other outcomes:
Locations:
city: Cumming
country: United States
facility: Atlanta Heart Specialist, LLC
state: Georgia
city: Tucker
country: United States
facility: Atlanta Heart Specialists, LLC
state: Georgia
Study officials:
affiliation: Atlanta Heart Specialists, LLC
name: Narendra Singh, MD
role: PRINCIPAL_INVESTIGATOR
References: