Ranolazine, Ethnicity and the Metabolic Syndrome

NCT01304095 | Unknown Phase 4

• 1 other identifier: AHS-REMS-001
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Coronary Artery Disease; Angina; Metabolic Syndrome

Keywords

Coronary Artery Disease, Angina, Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• fasting glucose

  change from baseline to 6 months

• Angina

  change from baseline to 6 months

• Concomitant medications

  change from baseline to 6 months

• lipid profile

  change from baseline to 6 months

• HgbA1c

  change from baseline to 6 months

Study Arms (2)

Ranolazine

ACTIVE COMPARATOR

Ranolazine in addition to standard of care medical therapy

Drug: Ranolazine

Standard of Care

NO INTERVENTION

Interventions

Ranolazine DRUG

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.

Also known as: Ranexa

Ranolazine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)
• Symptoms of angina or a suspected angina equivalent (upper body chest pain, shortness of breath, fatigue)

You may not qualify if:

• 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

Sponsors & Collaborators

• Atlanta Heart Specialists, LLC: lead
• Gilead Sciences: collaborator

Study Sites (2)

Atlanta Heart Specialist, LLC

Cumming, Georgia, 30041, United States

Location

Atlanta Heart Specialists, LLC

Tucker, Georgia, 30084, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Angina Pectoris; Metabolic Syndrome

Interventions

Ranolazine

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Narendra Singh, MD

  Atlanta Heart Specialists, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical Research-AHS

Study Record Dates

• First Submitted: February 16, 2011
• First Posted: February 25, 2011
• Study Start: January 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: November 1, 2013
• Last Updated: July 11, 2013

Record last verified: 2013-07

Locations

US (2)