Effectiveness of Ranolazine on Reducing Chest Pain in Patients With Blockage But no Stents

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Angina

In brief

To determine if ranolazine improves angina symptoms at 4 months compared with placebo among patients who are deferred for receiving a Percutaneous Coronary Intervention (PCI) based on the Fractional Flow Reserve (FFR) measurement.

Key facts

Study ID

NCT02147834

Run by

North Florida Foundation for Research and Education

People needed

5

Starts

2015-08-01

Expected to finish

2016-09-01

Last updated by the study team

2019-06-11

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Stable 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
• 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 insufficience (i.e. creatinine clearance < 30mL/min/1.73 m2)
• QTc > 500 milliseconds

Where it is running

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

Full record on ClinicalTrials.gov

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