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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
  Purpose

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.


Condition Intervention Phase
Myocardial Perfusion Imaging
Myocardial Ischemia
 Drug: Placebo
Drug: Ranolazine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Drug Information available for: Ranolazine
U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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


Enrollment: 81
Study Start Date: September 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Sugar pill 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
Active Comparator: Ranolazine 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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01221272

  Show 43 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Patrick Yue, MD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01221272     History of Changes
Other Study ID Numbers: GS-US-259-0103
Study First Received: October 13, 2010
Last Updated: November 14, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Canada: Health Canada
Canada: Ethics Review Committee
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
Finland: Ethics Committee
Finland: Finnish Medicines Agency
Israel: Ethics Commission
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: Ethics Committee
Italy: The Italian Medicines Agency
Singapore: Domain Specific Review Boards
Singapore: Health Sciences Authority
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Keywords provided by Gilead Sciences:
SPECT MPI

Additional relevant MeSH terms:
Myocardial Ischemia
Coronary Artery Disease
Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
 Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes
Ranolazine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013