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Study the Effects of Ranolazine on Myocardial Perfusion Assessed by Serial Quantitative Exercise SPECT Imaging

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01221272
First received: October 13, 2010
Last updated: November 14, 2012
Last verified: October 2012
History of Changes

October 13, 2010
November 14, 2012
September 2010
September 2012   (final data collection date for primary outcome measure)
Effect of ranolazine (versus placebo) on exercise-induced perfusion defect size (PDS) and on exercise-induced total perfusion deficit (TPD) [ Time Frame: 29 days. Subjects may be treated for up to 33 days due to visit windows. ] [ Designated as safety issue: Yes ]

Co-Primary Endpoints:

  • Effect of ranolazine (versus placebo) on exercise-induced perfusion defect size (PDS)
  • Effect of ranolazine (versus placebo) on exercise-induced total perfusion deficit (TPD)
Effect of ranolazine (versus placebo) on exercise-induced reversible PDS [ Time Frame: 30 days. Subjects may be treated for up to 34 days due to visit windows. ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01221272 on ClinicalTrials.gov Archive Site
Effect of ranolazine (versus placebo) on SPECT MPI variables [ Time Frame: 29 days. Subjects may be treated for up to 33 days due to visit windows. ] [ Designated as safety issue: Yes ]

1. Effect of ranolazine (versus placebo) on the following SPECT MPI variables:

  1. Exercise-induced perfusion defect severity
  2. Exercise-induced reversible PDS and TPD
Effect of ranolazine (versus placebo) on SPECT MPI variables [ Time Frame: 30 days. Subjects may be treated for up to 34 days due to visit windows. ] [ Designated as safety issue: Yes ]

Effect of ranolazine (versus placebo) on the following SPECT MPI variables:

  1. Total exercise-induced perfusion defect size and severity
  2. Summed difference score (SDS), summed stress score (SSS), and number of reversible segments using a 17-segment model
Not Provided
Not Provided
 
Study the Effects of Ranolazine on Myocardial Perfusion Assessed by Serial Quantitative Exercise SPECT Imaging
A Phase 4, Randomized, Double-Blind, Placebo-Controlled, Cross-over Trial to Evaluate the Effects of Ranolazine on Myocardial Perfusion Assessed by Serial Quantitative Exercise SPECT Imaging

The purpose of this study is to evaluate if ranolazine can improve blood flow to your heart (myocardial perfusion) by SPECT MPI when taken prior to exercise.

To evaluate the effect of ranolazine 1000 mg administered twice daily compared to placebo on exercise-induced myocardial perfusion defect size (PDS) and total perfusion deficit (TPD), assessed by gated single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) in subjects with documented exercise induced myocardial ischemia at baseline.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Myocardial Perfusion Imaging
  • Myocardial Ischemia
  • Drug: Placebo
    • One tablet in the evening on Day 1 of the period
    • One tablet, twice daily on Days 2-3 of the period
    • Two tablets, twice daily from Day 4 to the end of the period (Day 15 +/- 2 days) The last dose of each period must be taken 3-4 hours prior to conduct of the exercise SPECT MPI. After the research exercise SPECT MPI is performed at the end of Period 1, subjects will discontinue the study medication they were randomized to for that period and begin study drug for the next period at the starting dose of one tablet.
    Other Name: Sugar pill
  • 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) The last dose of each period must be taken 3-4 hours prior to conduct of the exercise SPECT MPI. After the research exercise SPECT MPI is performed at the end of Period 1, subjects will discontinue the study medication they were randomized to for that period and begin study drug for the next period at the starting dose of 500 mg.
    Other Name: Ranexa
  • Placebo Comparator: Sugar pill
    Intervention: Drug: Placebo
  • Active Comparator: Ranolazine
    Intervention: Drug: Ranolazine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
81
September 2012
September 2012   (final data collection date for primary outcome measure)

Key Inclusion Criteria:

  • Exercise SPECT MPI study (stress and rest) showing at least 10% reversible myocardial ischemia (as confirmed by the core nuclear laboratory) performed not more than 12 weeks prior to Screening, OR
  • Exercise SPECT MPI study (stress and rest) conducted during screening (after consultation with the Medical Monitor and after informed consent has been obtained) showing at least 10% reversible myocardial ischemia (as confirmed by the core nuclear laboratory)
  • Stable antianginal medical therapy (excluding short-acting nitroglycerin)

Key Exclusion Criteria:

  • Left bundle branch block
  • Automated implantable defibrillator and/or pacemaker (selected subjects with permanent pacemakers who have an intact sinus mechanism may be included following consultation with the Medical Monitor)
  • Intervening coronary revascularization between the time of qualifying exercise SPECT MPI study and Randomization
  • Acute myocardial infarction within 60 days prior to Screening or at any time after the qualifying exercise SPECT MPI study, or MI undergoing staged intervention during a subject's participation in the trial
  • Unstable angina within 30 days prior to Screening, or at any time after the qualifying exercise SPECT MPI study
  • Coronary artery bypass graft (CABG) surgery within 60 days prior to Screening or at any time after the qualifying exercise SPECT MPI study, or percutaneous coronary intervention (PCI) within 30 days prior to Screening or at any time after the qualifying exercise SPECT MPI study
  • Anticipated coronary revascularization during the trial period
  • Cerebrovascular Attack (CVA) or Transient Ischemic Attack (TIA) within 90 days prior to Screening
  • History of serious arrhythmias
  • Currently in atrial fibrillation or atrial flutter
  • QTc interval > 500 milliseconds
  • Diagnosed as having New York Heart Association (NYHA) Class III or IV heart failure
  • Inability to exercise or exercise limitation due to other co morbidities that may interfere with ability to perform required exercise SPECT MPI study
  • Body Mass Index (BMI) greater than or equal to 38 kg/m2 (may be up to 40 kg/m2 after consultation with the Medical Monitor)
  • Any absolute contraindications to exercise stress testing
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Czech Republic,   Finland,   Israel,   Italy,   Singapore,   United Kingdom
 
NCT01221272
GS-US-259-0103
No
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Patrick Yue, MD Gilead Sciences
Gilead Sciences
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP