Trial | NCT01304095  Report issue

Title

Ranolazine, Ethnicity and the Metabolic Syndrome
Ranolazine, Ethnicity and the Metabolic Syndrome - REMS Study

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    ranolazine ...

  • Study Participants

    160
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.
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 Started
Jan 31
2011
Primary Completion
Jul 31
2013
Study Completion
Nov 30
2013
Anticipated
Last Update
Jul 11
2013
Estimate

Drug Ranolazine

Patients in the ranolazine arm would start with 500 mg po BID of ranolazine and be force titrated to 1gm po BID after 2 weeks. Down-titration would only be allowed for side effects. This would be on top of all standard medical therapy.

  • Other names: Ranexa

Ranolazine Active Comparator

Ranolazine in addition to standard of care medical therapy

Standard of Care No Intervention

Criteria 

Inclusion Criteria:

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

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
No Results Posted