View Clinical Trial (Medical Research Study)
Ranolazine, Ethnicity and the Metabolic Syndrome - REMS Study
| City: |
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Tucker |
| State: |
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Georgia |
| Zip Code: |
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30084 |
| Conditions: |
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Coronary Artery Disease - Angina Pectoris - Metabolic Syndrome |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT01304095 |
| Primary Contact: |
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Principal Investigator
Narendra Singh, MD
Atlanta Heart Specialists, LLC
Narendra Singh, MD
Phone: 678-679-6800
Email: drsingh@ahsmed.com
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| Backup Contact: |
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Email: holly@ahsmed.com
Holly Adams, RN, CCRC
Phone: 770-407-6369
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| Location Contact: |
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Tucker, Georgia 30084
United States
Holly Adams, RN, CCRC
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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