NCT02252406.

Trial name or title	NCT02252406
Methods	Study design: parallel‐group Duration of follow‐up: 24 weeks Method of randomisation: not described Method of concealment of allocation: not described Blinding: double‐blind (Subject, Caregiver, Investigator, Outcomes Assessor) Power calculation: not mentioned Phases of the study: 1 (treatment phase)
Participants	Total number: 40 (estimated) Country of enrolment: not described Setting/location: not specified Diagnostic criteria (stable angina pectoris): symptoms of chronic stable angina and evidence of CAD (macrovascular angina) Comorbidities: Metabolic Syndrome Inclusion criteria: Patients with chronic stable angina (> 3 months) and symptomatic >=3 attacks/week on evidence based adequate therapy Evidence of stable coronary artery disease by any of these: MI, PCI or CABG > 30 days prior to enrolment 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: Contraindications to use of Ranexa, including patients on CYP3A4 inducers/potent inhibitors, and patients with liver cirrhosis Patients with CrCl < 30 mL/min Limit dose of Ranexa to 500 mg BID in patients on concurrent diltiazem/verapamil Limit concurrent simvastatin to 20 mg/day Limit concurrent metformin to 1000 mg/day Additional exclusion Patients with variable ‐inconsistent symptoms Patients with unstable coronary artery disease or revascularisation within 30 days of enrolment Patients who have known severe liver disease Patients already receiving maximal ranolazine therapy for more than 4 weeks Presence of diabetes, hypothyroidism, active infection, cancer 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 randomisation 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 (e.g. 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 (e.g. ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir) OR strong CYP3A inducers (e.g. rifampin, rifabutin, rifapentine, phenobarbital, phenytoin,carbamazepine, and St. John's Wort) is a contraindication
Interventions	Number of intervention groups: 2 Concomitant medications: not described Excluded medications: those mentioned in exclusion criteria Placebo group Intervention: placebo Duration of intervention: 24 weeks Ranolazine group Intervention: ranolazine (type of formulation not specified) 500 mg twice daily Duration of intervention: 24 weeks
Outcomes	Total number of outcomes: (angina frequency (SAQ scale), biomarkers) OUTCOMES No outcome meets the inclusion criteria
Starting date	September 2015
Contact information	Gladys Velarde, MD 904‐244‐43095 gladys.velarde@jax.ufl.edu
Notes	Source of funding: University of Florida