Ranolazine Among Unrevascularized Chronic Stable Angina Patients

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: North Florida Foundation for Research and Education
• Collaborator: Gilead Sciences
• Treatments: Ranolazine

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) <=0.8 and PCI deferred

Exclusion Criteria:

• Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) during the index procedure or anticipated within the next month

• acute coronary syndrome or cardiogenic shock

• QTc > 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)