Effect of Ranolazine After Deferral of Percutaneous Coronary Intervention by Fractional Flow Reserve (IMWELL3)
Status: Terminated
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:
• 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
Locations
United States
Florida
North Florida/South Georgia Veterans Health System
Gainesville
Time Frame
Start Date: 2015-08
Completion Date: 2016-09
Participants
Target number of participants: 5
Treatments
Active_comparator: Ranolazine
Ranolazine 500mg tablet~1. 500mg tablet two times per day for 7 days then,~2. 500mg tablet (1000mg) two times per day for 15 weeks
Placebo_comparator: Sugar pill
Sugar pill that looks like the drug ranolazine 500mg tablet~1. 500mg tablet two times per day for 7 days then,~2. 500mg tablet (1000mg) two times per day for 15 weeks
Authors
Related Therapeutic Areas
Sponsors
Collaborators: University of Florida, Gilead Sciences
Leads: North Florida Foundation for Research and Education