Ranolazine, Ethnicity and the Metabolic Syndrome

Coronary Artery Disease Clinical Trial

— REMS  

Official title:

Ranolazine, Ethnicity and the Metabolic Syndrome - REMS Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01304095
• Other study ID #: AHS-REMS-001
• Status: Active, not recruiting
• Phase: Phase 4
• First received: February 16, 2011
• Last updated: July 9, 2013
• Start date: January 2011
• Est. completion date: November 2013

Study information

• Verified date: July 2013
• Source: Atlanta Heart Specialists, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: November 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina
• Coronary Artery Disease
• Coronary Disease
• Metabolic Syndrome
• Metabolic Syndrome X
• Myocardial Ischemia
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	Atlanta Heart Specialist, LLC	Cumming	Georgia
United States	Atlanta Heart Specialists, LLC	Tucker	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Atlanta Heart Specialists, LLC	Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise Duration	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.	change from baseline to 6 months	No
Secondary	fasting glucose	To measure the effect ranolazine has on fasting blood glucose.	change from baseline to 6 months	No
Secondary	Angina	To look at the effect of ranolazine on anginal episodes using the Seattle Angina Questionnaire (SAQ).	change from baseline to 6 months	No
Secondary	Concomitant medications	To measure the impact of ranolazine on reducing concomitant medication therapy such as anti-arrhythmic agents, hypoglycemic agents, and nitrates.	change from baseline to 6 months	No
Secondary	lipid profile	To measure the effect ranolazine has on lipid profile.	change from baseline to 6 months	No
Secondary	HgbA1c	To measure the effect ranolazine has on hemoglobin A1c.	change from baseline to 6 months	No