Ranolazine, Ethnicity and the Metabolic Syndrome (REMS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Narendra Singh, MD, Atlanta Heart Specialists, LLC
ClinicalTrials.gov Identifier:
NCT01304095
First received: February 16, 2011
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Angina
Metabolic Syndrome
Drug: Ranolazine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ranolazine, Ethnicity and the Metabolic Syndrome - REMS Study

Resource links provided by NLM:


Further study details as provided by Atlanta Heart Specialists, LLC:

Primary Outcome Measures:
  • Exercise Duration [ Time Frame: change from baseline to 6 months ] [ Designated as safety issue: No ]
    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:
  • fasting glucose [ Time Frame: change from baseline to 6 months ] [ Designated as safety issue: No ]
    To measure the effect ranolazine has on fasting blood glucose.

  • Angina [ Time Frame: change from baseline to 6 months ] [ Designated as safety issue: No ]
    To look at the effect of ranolazine on anginal episodes using the Seattle Angina Questionnaire (SAQ).

  • Concomitant medications [ Time Frame: change from baseline to 6 months ] [ Designated as safety issue: No ]
    To measure the impact of ranolazine on reducing concomitant medication therapy such as anti-arrhythmic agents, hypoglycemic agents, and nitrates.

  • lipid profile [ Time Frame: change from baseline to 6 months ] [ Designated as safety issue: No ]
    To measure the effect ranolazine has on lipid profile.

  • HgbA1c [ Time Frame: change from baseline to 6 months ] [ Designated as safety issue: No ]
    To measure the effect ranolazine has on hemoglobin A1c.


Estimated Enrollment: 160
Study Start Date: January 2011
Estimated Study Completion Date: November 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ranolazine
Ranolazine in addition to standard of care medical therapy
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 Name: Ranexa
No Intervention: Standard of Care

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01304095

Locations
United States, Georgia
Atlanta Heart Specialist, LLC
Cumming, Georgia, United States, 30041
Atlanta Heart Specialists, LLC
Tucker, Georgia, United States, 30084
Sponsors and Collaborators
Atlanta Heart Specialists, LLC
Gilead Sciences
Investigators
Principal Investigator: Narendra Singh, MD Atlanta Heart Specialists, LLC
  More Information

No publications provided

Responsible Party: Narendra Singh, MD, Director, Clinical Research-AHS, Atlanta Heart Specialists, LLC
ClinicalTrials.gov Identifier: NCT01304095     History of Changes
Other Study ID Numbers: AHS-REMS-001
Study First Received: February 16, 2011
Last Updated: July 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Atlanta Heart Specialists, LLC:
Coronary Artery Disease, Angina, Metabolic Syndrome

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Metabolic Syndrome X
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Ranolazine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014