Phase 4
N=33
Impact of Ranolazine in Blood Markers in Women With Angina and Metabolic Syndrome
Stable Angina · Metabolic Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02252406 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Impact of Ranolazine on Hemoglobin A1C — -5; 2.6 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ranolazine (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- Female
- Sponsor
- University of Florida
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Impact of Ranolazine on Hemoglobin A1C |
-5; 2.6 | — |
| PRIMARY Impact of Ranolazine on HDL-C Levels in Subjects |
6.6; 6.5 | — |
Summary
The purpose of this study is to determine the effects of ranolazine on different markers of cardiometabolic disease in women with stable angina.
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 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.
Data sourced from ClinicalTrials.gov (NCT02252406). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.