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Ranolazine, Ethnicity and the Metabolic Syndrome (REMS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Atlanta Heart Specialists, LLC.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Gilead Sciences
Information provided by:
Atlanta Heart Specialists, LLC
ClinicalTrials.gov Identifier:
NCT01304095
First received: February 16, 2011
Last updated: February 24, 2011
Last verified: February 2011
History of Changes
  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 Pectoris
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:

Drug Information available for: Ranolazine
U.S. FDA Resources

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: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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 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

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

Contacts
Contact: Narendra Singh, MD 678-679-6800 drsingh@ahsmed.com
Contact: Holly Adams, RN, CCRC 770-407-6369 holly@ahsmed.com

Locations
United States, Georgia
Atlanta Heart Specialist, LLC Recruiting
Cumming, Georgia, United States, 30041
Contact: Holly Adams, RN, CCRC            
Principal Investigator: Narendra Singh, MD            
Atlanta Heart Specialists, LLC Recruiting
Tucker, Georgia, United States, 30084
Contact: Holly Adams, RN, CCRC            
Principal Investigator: Narendra Singh, MD            
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, 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: February 24, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Angina Pectoris
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Metabolic Syndrome X
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
 Arteriosclerosis
Arterial Occlusive 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 May 16, 2013