title: Improvement of Subjective Well-Being by Ranolazine in Patients with Chronic Angina and Known Myocardial Ischemia (IMWELL Study).
abstract: BACKGROUND
  We aimed to assess if ranolazine would improve angina symptoms among patients with documented myocardial ischemia.
  
  
  METHODS
  Eligible subjects had chronic stable angina and at least one coronary stenosis with fractional flow reserve (FFR) ≤0.80 or at least one chronic total occlusion (CTO) without attempted revascularization. Subjects were randomized to oral ranolazine 500 mg twice daily for 1 week, then ranolazine 1000 mg twice daily for 15 weeks versus matching placebo. The primary end point was change in angina at 16 weeks as assessed by the Seattle Angina Questionnaire (SAQ).
  
  
  RESULTS
  Between September 2014 and January 2016, 25 subjects were randomized to ranolazine versus 25 to placebo. The most common reason for eligibility was CTO (72%), while the remainder had myocardial ischemia documented by low FFR. The mean FFR was 0.57 ± 0.12. Sixty-eight percent of subjects were on two or more anti-angina medications at baseline. Study medication was discontinued in 32% (eight of 25) of the ranolazine group versus 36% (nine of 25) of the placebo group. By intention-to-treat, 46 subjects had baseline and follow-up SAQ data completed. Ranolazine was not associated with an improvement in angina compared with placebo at 16 weeks. The results were similar among 33 subjects that completed study medication. The incidence of ischemia-driven hospitalization or catheterization was 12% (three of 25) of the ranolazine group versus 20% (five of 25) in the placebo group (p > 0.05).
  
  
  CONCLUSIONS
  In subjects with chronic stable angina and documented myocardial ischemia, ranolazine did not improve angina symptoms at 16 weeks.
  
  
  BACKGROUND
  Gilead.
  
  
  BACKGROUND
  The study was registered at ClinicalTrials.gov (NCT02265796).
authors.affiliation: Department of Medicine, University of Florida, Gainesville, FL, USA. anthony.bavry@va.gov.|North Florida/South Georgia Veterans Health System, Gainesville, FL, USA. anthony.bavry@va.gov.
authors.forename: Anthony A
authors.initials: AA
authors.lastname: Bavry
authors.affiliation: Department of Medicine, University of Florida, Gainesville, FL, USA.|North Florida/South Georgia Veterans Health System, Gainesville, FL, USA.
authors.forename: Ki E
authors.initials: KE
authors.lastname: Park
authors.affiliation: Department of Medicine, University of Florida, Gainesville, FL, USA.|North Florida/South Georgia Veterans Health System, Gainesville, FL, USA.
authors.forename: Calvin Y
authors.initials: CY
authors.lastname: Choi
authors.affiliation: Department of Medicine, University of Florida, Gainesville, FL, USA.
authors.forename: Ahmed N
authors.initials: AN
authors.lastname: Mahmoud
authors.affiliation: Department of Medicine, University of Florida, Gainesville, FL, USA.|Health Outcomes, College of Pharmacy, University of Rhode Island, Kingston, RI, USA.
authors.forename: Xuerong
authors.initials: X
authors.lastname: Wen
authors.affiliation: Department of Medicine, University of Florida, Gainesville, FL, USA.
authors.forename: Islam Y
authors.initials: IY
authors.lastname: Elgendy
keywords: Angina; Coronary artery disease; Randomized controlled trial; Ranolazine; Revascularization; Stable