The purpose of this study is to determine the effects of ranolazine on different markers of cardiometabolic disease in women with stable angina.
Full Title of Study: “Impact of Ranolazine on Inflammatory, Thrombogenic, Lipogenic, Biomarkers in Women With Angina and Metabolic Syndrome.”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: December 17, 2018
Evaluate the ability of ranolazine to favorably modify thrombogenic, inflammatory, lipogenic, oxidative stress and hormonal biomarkers in a relatively short period of time in a group of ethnically diverse women with chronic stable angina and metabolic syndrome.
- Drug: Ranolazine
- Ranolazine 500 mg from baseline to week 3 and 1000 mg thereafter until week 24
- Other: Placebo
- Matching placebo tablets daily for 24 weeks.
Arms, Groups and Cohorts
- Experimental: Ranolazine
- Ranolazine would start with 500 mg BID and be force titrated to 1 gram po BID after 3 weeks. Down titration would only be allowed for side effects. This would be on top of all standard medical therapy.
- Placebo Comparator: Placebo
- Placebo arm would start with 500 mg matching placebo tablet BID and be force titrated to 1 gram matching placebo tablet twice a day after 3 weeks. Down titration would only be allowed for side effects (if reported). This would be on top of all standard medical therapy.
Clinical Trial Outcome Measures
- Impact of Ranolazine on Hemoglobin A1C
- Time Frame: Change from baseline to 24 weeks
- Will evaluate the impact of ranolazine in HgbA1C in women with Metabolic Syndrome (MBS)
- Impact of Ranolazine on HDL-C Levels in Subjects
- Time Frame: Change from Baseline to 24 weeks
- Will evaluate the impact of ranolazine in HDL-C levels in women with metabolic syndrome
Participating in This Clinical Trial
- Patients with chronic stable angina (> 3 months) on evidence based adequate therapy
- Evidence of stable coronary artery disease by any of these:
- MI, PCI or CABG > 30 days prior to enrollment or
- Angiography showing > 50% stenosis in major vessel, branch or bypass graft > 30 days of enrollment or
- Abnormal stress MPI nuclear study, or DBA stress echo where the decision has been to treat medically and where angina has remained stable for >= 3 months
- Evidence of the Metabolic Syndrome: As defined by ATP III criteria i.e 3/5 of following Abdominal circumference F > 88 cm (35 in), M > 102 cm (40 in) Hypertriglyceridemia ≥ 150 mg/dl HDL F < 50 mg/dl M < 40 mg/dl Blood Pressure ≥130/85 Fasting Glucose ≥100 mg/dl For reproductive age women, a negative urine pregnancy test is required if all other inclusion criteria are met.
- Exclusion of patients with contraindications to use of RANEXA, including patients on CYP3A4 inducers/potent inhibitors, and patients with liver cirrhosis.
- Exclusion of Patients with CrCl < 30 mL/min
- Limit dose of RANEXA to 500mg BID in patients on concurrent diltiazem/ verapamil
- Limit concurrent simvastatin to 20 mg/day
- Limit concurrent metformin to 1700 mg/day Additional Exclusion
- Patients with variable -inconsistent symptoms
- Patients with unstable coronary artery disease or revascularization within 30 days of enrollment.
- Patients who have known severe liver disease.
- Patients already receiving maximal ranolazine therapy for more than 4 weeks
- Presence of diabetes (AIC≥ 6.5 and /or on insulin therapy or anti-diabetic medication other than metformin) unstable hypothyroidism, active infection, active cancer (or ongoing chemotherapy and/or radiation within a year who are not on remission) and/or recent major surgery or illness.
- Patients with any contraindication to ranolazine see above
- Women of reproductive age are excluded if they are planning to become pregnant in the next 6 -12 months after randomization.
- Patients who are pregnant or lactating
- Documented allergic reaction to ranolazine in the past.
- Unexplained prolongation of the QTc > 500 milliseconds.
- Current or planned co-administration of moderate CYP3A inhibitors (eg, diltiazem, verapamil, aprepitant, erythromycin, fluconazole, and grapefruit juice or grapefruit-containing products) is not a full contraindication, if meet inclusion criteria otherwise, these patients could be accepted in trial but dose will be limited to 500 mg BID as stated previously.
- Current or planned co-administration of strong CYP3A inhibitors (eg, ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir) OR strong CYP3A inducers (eg, rifampin, rifabutin, rifapentine, phenobarbital, phenytoin,carbamazepine, and St. John's Wort) is a contraindication.
Gender Eligibility: Female
Minimum Age: 30 Years
Maximum Age: 75 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- University of Florida
- Provider of Information About this Clinical Study
- Overall Official(s)
- Gladys P Velarde, MD, FACC, Principal Investigator, University of Florida
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