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

NCT02252406 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: WIRB20141202
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Stable Angina; Metabolic Syndrome

Keywords

Stable Angina; Metabolic Syndrome; Women; Biomarkers

Outcome Measures

Primary Outcomes (2)

• Impact of Ranolazine on Hemoglobin A1C

  Will evaluate the impact of ranolazine in HgbA1C in women with Metabolic Syndrome (MBS)

  Change from baseline to 24 weeks

• Impact of Ranolazine on HDL-C Levels in Subjects

  Will evaluate the impact of ranolazine in HDL-C levels in women with metabolic syndrome

  Change from Baseline to 24 weeks

Study Arms (2)

Ranolazine

EXPERIMENTAL

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.

Drug: Ranolazine

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Ranolazine DRUG

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

Also known as: Ranexa

Ranolazine

Placebo OTHER

Matching placebo tablets daily for 24 weeks.

Placebo

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Limit dose of RANEXA to 500mg BID in patients on concurrent diltiazem/ verapamil
• Limit concurrent simvastatin to 20 mg/day
• 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 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Jacksonville, Florida, 32209, United States

Location

MeSH Terms

Conditions

Angina, Stable; Metabolic Syndrome

Interventions

Ranolazine

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Gladys Velarde, MD
• Organization: University of Florida, Jacksonville

gladys.velarde@jax.ufl.edu

904-244-2060

Study Officials

• Gladys P Velarde, MD, FACC

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2014
• First Posted: September 30, 2014
• Study Start: September 1, 2015
• Primary Completion: December 17, 2018
• Study Completion: May 17, 2019
• Last Updated: April 10, 2020
• Results First Posted: April 10, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)