Conditions: Myocardial Perfusion Imaging Myocardial Ischemia
Keywords: SPECT MPI
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 81
Healthy volunteers: no

Brief summary:
This study enrolled participants with documented exercise-induced myocardial ischemia in order to evaluate whether ranolazine, when taken prior to exercise, can improve blood flow to the heart (myocardial perfusion), as assessed by exercise-induced myocardial perfusion defect size (PDS) and total perfusion deficit (TPD), using gated single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI).

This was a 2-period crossover study. The last dose of each period must have been taken 3-4 hours prior to conduct of the exercise SPECT MPI. After the research exercise SPECT MPI was performed at the end of Period 1, participants discontinued the treatment they were randomized to for that period and began the other treatment in Period 2.

Detailed description:

Arms:
arm 1: Participants received ranolazine from Day 1 through Day 15 (± 2 days) of Period 1, followed by an exercise SPECT MPI study, then received placebo to match ranolazine from Day 1 through Day 15 (± 2 days) of Period 2, followed by an exercise SPECT MPI study. arm 2: Participants received placebo to match ranolazine from Day 1 through Day 15 (± 2 days) of Period 1, followed by an exercise SPECT MPI study, then received ranolazine from Day 1 through Day 15 (± 2 days) of Period 2, followed by an exercise SPECT MPI study.

Interventions: intervention 1: Ranolazine intervention 2: Placebo to match ranolazine intervention 3: SPECT MPI intervention 4: Exercise
Intervention descriptions: intervention 1: * One 500 mg tablet in the evening on Day 1 of the period
* One 500 mg tablet, twice daily on Days 2-3 of the period
* Two 500 mg tablets (1000 mg total), twice daily from Day 4 to the end of the period (Day 15 ± 2 days) intervention 2: Placebo to match ranolazine administered in the same form and frequency as the active drug. intervention 3: Gated single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) to confirm the presence of reversible exercise-induced left ventricular perfusion defect size (PDS) performed within 12 weeks prior to baseline or at the baseline visit, and at the end-of-period 1 and end-of-period 2 visits. intervention 4: Treadmill stress test

Protocol document: