Trials / Unknown
UnknownNCT01304095
Ranolazine, Ethnicity and the Metabolic Syndrome
Ranolazine, Ethnicity and the Metabolic Syndrome - REMS Study
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- Sponsor
- Atlanta Heart Specialists, LLC · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ranolazine | 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. |
Timeline
- Start date
- 2011-01-01
- Primary completion
- 2013-07-01
- Completion
- 2013-11-01
- First posted
- 2011-02-25
- Last updated
- 2013-07-11
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01304095. Inclusion in this directory is not an endorsement.