Impact of Ranolazine in Blood Markers in Women With Angina and Metabolic Syndrome

• Status: Completed
• Trial end date: 2019-05-17
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to determine the effects of ranolazine on different markers of cardiometabolic disease in women with stable angina.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Treatments: Ranolazine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.