Ranolazine, Ethnicity and the Metabolic Syndrome (REMS)
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|ClinicalTrials.gov Identifier: NCT01304095|
Recruitment Status : Unknown
Verified July 2013 by Narendra Singh, MD, Atlanta Heart Specialists, LLC.
Recruitment status was: Active, not recruiting
First Posted : February 25, 2011
Last Update Posted : July 11, 2013
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease Angina Metabolic Syndrome||Drug: Ranolazine||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ranolazine, Ethnicity and the Metabolic Syndrome - REMS Study|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||July 2013|
|Estimated Study Completion Date :||November 2013|
Active Comparator: Ranolazine
Ranolazine in addition to standard of care medical therapy
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|
- Exercise Duration [ Time Frame: change from baseline to 6 months ]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.
- fasting glucose [ Time Frame: change from baseline to 6 months ]To measure the effect ranolazine has on fasting blood glucose.
- Angina [ Time Frame: change from baseline to 6 months ]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 ]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 ]To measure the effect ranolazine has on lipid profile.
- HgbA1c [ Time Frame: change from baseline to 6 months ]To measure the effect ranolazine has on hemoglobin A1c.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01304095
|United States, Georgia|
|Atlanta Heart Specialist, LLC|
|Cumming, Georgia, United States, 30041|
|Atlanta Heart Specialists, LLC|
|Tucker, Georgia, United States, 30084|
|Principal Investigator:||Narendra Singh, MD||Atlanta Heart Specialists, LLC|