Phase 2
Completed N=50
Ranolazine Among Unrevascularized Chronic Stable Angina Patients
Source: ClinicalTrials.gov NCT02265796 ↗Enrolled (actual)
50
Serious AEs
18.0%
Results posted
Dec 2017
Primary outcomePrimary: Seattle Angina Questionnaire Score Change From Baseline to 16 Weeks — 48; 50; 40; 60 units on a scale — p=>0.05
Summary
This is a prospective, double-blind, placebo-controlled, randomized, single-center (North Florida- South Georgia VA Medical Center) study. The study objective is to determine if ranolazine improves angina symptoms at 4 months compared with placebo among stable coronary artery disease patients who have demonstrable myocardial ischemia, but who do not undergo revascularization
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Seattle Angina Questionnaire Score Change From Baseline to 16 Weeks |
48; 50; 40; 60; -7; 6 | >0.05 |
| SECONDARY Subjective Well Being |
9; 6; 12; 16; 1; 2 | 0.58 |
| SECONDARY Ischemia Driven Revascularization or Hospitalization |
3; 5 | >0.05 |
Eligibility Criteria
Inclusion Criteria
- Adult patients >= 18 years of age referred for cardiac catheterization for evaluation of cardiac symptoms ( angina, fatigue, or shortness of breath)
- At least 1 indeterminate stenosis (20-80%),
- Fractional flow reserve (FFR) 500 milliseconds
- use of strong inhibitors of CTP3A (i.e. ketoconazole, itraconazole, clarithromycin,nefazodone, nelfinavir, ritonavir, indinavir and saquinavir)
- use of inducers of CYP3A (i.e. rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, and St. John's wort)
- liver cirrhosis
- sever renal insufficiency (i.e. creatinine clearance < 30mL/min/1.73 m2)
Data sourced from ClinicalTrials.gov (NCT02265796). 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. Informational only — not medical advice.