Ranolazine Among Unrevascularized Chronic Stable Angina Patients

Completed · Phase 2 · Has a placebo group

Conditions studied: Angina

In brief

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

Key facts

Study ID

NCT02265796

Run by

North Florida Foundation for Research and Education

People needed

50

Starts

2014-09-01

Expected to finish

2016-09-01

Last updated by the study team

2019-08-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• North Florida/South Georgia Veterans Health System — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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