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Clinical Trial Details

Title
IRMA 2014: Impact of Ranolazine on Inflammatory, Thrombogenic, Lipogenic, Biomarkers in Women with Angina and Metabolic Syndrome
Study Purpose
More than 5 million women are living with chronic stable angina (CSA) today compared to 4 million men. Similarly more women than men are affected with the metabolic syndrome (MBS). MBS is a group of cardiovascular risk factors such as pre-hypertension, poorly controlled cholesterol, and poorly controlled glucose levels. The metabolic syndrome leads to an increased risk of cardiovascular disease and type 2 diabetes in apparently healthy individuals. It is associated with advanced vascular damage and poorer health outcomes in those with cardiovascular disease (CVD). The reason for this gender difference in angina and MBS is unclear. Ranolazine is a drug the Food and Drug Administration (FDA) has approved for the treatment of angina. It has also had favorable effects on glycemic control. The purpose of this study is to investigate the potential additional benefits of ranolazine in women with CVD and MBS and to evaluate the ability of ranolazine to decrease angina. Secondary, this study will look at certain biomarkers in a group of ethnically diverse women with CSA and with MBS.
Study Plan
Your study doctor will fully explain the study, other possible treatments, and any known or possible side effects of participating in this study. If you consent to participate in this study, your study doctor will collect data from your medical records. If you are a woman of childbearing potential, a pregnancy test will be done. If you are found to be pregnant, you will not be eligible for this study. Other study related procedures will include a physical examination with measurement of your blood pressure, heart rate, pulse, waist circumference, assessment of height and weight. Blood will be drawn to assess if diagnosis of metabolic syndrome is present. If you are eligible to participate you will be assigned to either a placebo (sugar tablet) or the medication ranolazine. - Subjects assigned to ranolazine will start with 500 mg given by mouth twice a day for three weeks. Then the dose will be increased to1gm given by mouth twice a day. This will be in addition to your regular prescribed medication. - Subjects assigned to the placebo arm will start with 500 mg matching placebo tablets given by mouth twice a day for three weeks. Then the dose will be increased to1gm given by mouth twice a day. This will be in addition to your regular prescribed medication. After randomization you will have blood drawn at 12 and 24 weeks. Approximately 2-5 tablespoons of blood will be collected from you by inserting a needle directly into your vein.
Investigators

Principal Investigator
Gladys P. Velarde, M.D., FACC, FAHA
Medicine