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

NCT ID: NCT02252406

Last Updated: 2020-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2019-05-17

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.

Conditions

Stable Angina; Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Ranolazine

Intervention Type: DRUG

Ranolazine 500 mg from baseline to week 3 and 1000 mg thereafter until week 24

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Matching placebo tablets daily for 24 weeks.

Interventions

Ranolazine

Ranolazine 500 mg from baseline to week 3 and 1000 mg thereafter until week 24

Intervention Type: DRUG

Placebo

Matching placebo tablets daily for 24 weeks.

Intervention Type: OTHER

Other Intervention Names

Ranexa

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

• 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.

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gladys P Velarde, MD, FACC

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida

Jacksonville, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

WIRB20141202

Identifier Type: -

Identifier Source: org_study_id