MedTrace Logo

Effect of Ranolazine on Myocardial Perfusion Assessed by Serial Quantitative Exercise SPECT Imaging

NCT01221272 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2014-09-03

Study results available
· View outcomes & findings →

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.

Conditions

  • Myocardial Perfusion Imaging
  • Myocardial Ischemia

Interventions

DRUG

Ranolazine

* 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)

DRUG

Placebo to match ranolazine

Placebo to match ranolazine administered in the same form and frequency as the active drug.

PROCEDURE

SPECT MPI

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.

BEHAVIORAL

Exercise

Treadmill stress test

Sponsors & Collaborators

Principal Investigators

  • Patrick Yue, MD · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United States
  • Canada
  • Czechia
  • Finland
  • Israel
  • Italy
  • Singapore
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01221272 on ClinicalTrials.gov