Clinical trial NCT02252406: Impact of Ranolazine in Blood Markers in Women With Angina and Metabolic Syndrome
Official title: Impact of Ranolazine on Inflammatory, Thrombogenic, Lipogenic, Biomarkers in Women With Angina and Metabolic Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stable Angina
Metabolic Syndrome
Keywords: Stable Angina
Metabolic Syndrome
Women
Biomarkers
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2014-09-30
Enrollment: 33
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Impact of Ranolazine on Hemoglobin A1C
timeFrame: Change from baseline to 24 weeks
measure: Impact of Ranolazine on HDL-C Levels in Subjects
timeFrame: Change from Baseline to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Gladys P Velarde, MD, FACC
role: PRINCIPAL_INVESTIGATOR
References: