Overview

This trial is active, not recruiting.

Conditions coronary artery disease, angina, metabolic syndrome
Treatment ranolazine
Phase phase 4
Sponsor Atlanta Heart Specialists, LLC
Collaborator Gilead Sciences
Start date January 2011
End date July 2013
Trial size 160 participants
Trial identifier NCT01304095, AHS-REMS-001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Ranolazine in addition to standard of care medical therapy
ranolazine Ranexa
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.
(No Intervention)

Primary Outcomes

Measure
Exercise Duration
time frame: change from baseline to 6 months

Secondary Outcomes

Measure
fasting glucose
time frame: change from baseline to 6 months
Angina
time frame: change from baseline to 6 months
Concomitant medications
time frame: change from baseline to 6 months
lipid profile
time frame: change from baseline to 6 months
HgbA1c
time frame: change from baseline to 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Ranolazine, Ethnicity and the Metabolic Syndrome - REMS Study
Principal investigator Narendra Singh, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2013.
Information provided to ClinicalTrials.gov by Atlanta Heart Specialists, LLC.