search
Back to results

Ranolazine, Ethnicity and the Metabolic Syndrome (REMS)

Primary Purpose

Coronary Artery Disease, Angina, Metabolic Syndrome

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ranolazine
Sponsored by
Atlanta Heart Specialists, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, Angina, Metabolic Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Atlanta Heart Specialist, LLC
  • Atlanta Heart Specialists, LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Ranolazine

Standard of Care

Arm Description

Ranolazine in addition to standard of care medical therapy

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
February 16, 2011
Last Updated
July 9, 2013
Sponsor
Atlanta Heart Specialists, LLC
Collaborators
Gilead Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT01304095
Brief Title
Ranolazine, Ethnicity and the Metabolic Syndrome
Acronym
REMS
Official Title
Ranolazine, Ethnicity and the Metabolic Syndrome - REMS Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
November 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Atlanta Heart Specialists, LLC
Collaborators
Gilead Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Angina, Metabolic Syndrome
Keywords
Coronary Artery Disease, Angina, Metabolic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ranolazine
Arm Type
Active Comparator
Arm Description
Ranolazine in addition to standard of care medical therapy
Arm Title
Standard of Care
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Ranolazine
Other Intervention Name(s)
Ranexa
Intervention Description
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.
Primary Outcome Measure Information:
Title
Exercise Duration
Description
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.
Time Frame
change from baseline to 6 months
Secondary Outcome Measure Information:
Title
fasting glucose
Description
To measure the effect ranolazine has on fasting blood glucose.
Time Frame
change from baseline to 6 months
Title
Angina
Description
To look at the effect of ranolazine on anginal episodes using the Seattle Angina Questionnaire (SAQ).
Time Frame
change from baseline to 6 months
Title
Concomitant medications
Description
To measure the impact of ranolazine on reducing concomitant medication therapy such as anti-arrhythmic agents, hypoglycemic agents, and nitrates.
Time Frame
change from baseline to 6 months
Title
lipid profile
Description
To measure the effect ranolazine has on lipid profile.
Time Frame
change from baseline to 6 months
Title
HgbA1c
Description
To measure the effect ranolazine has on hemoglobin A1c.
Time Frame
change from baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Narendra Singh, MD
Organizational Affiliation
Atlanta Heart Specialists, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atlanta Heart Specialist, LLC
City
Cumming
State/Province
Georgia
ZIP/Postal Code
30041
Country
United States
Facility Name
Atlanta Heart Specialists, LLC
City
Tucker
State/Province
Georgia
ZIP/Postal Code
30084
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Ranolazine, Ethnicity and the Metabolic Syndrome

We'll reach out to this number within 24 hrs