Effect 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: August 21, 2014
Last verified: August 2014
Results First Received: July 1, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Myocardial Perfusion Imaging
Myocardial Ischemia
Interventions: Drug: Ranolazine
Drug: Placebo to match ranolazine
Procedure: SPECT MPI
Behavioral: Exercise

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled in a total of 27 study sites in the United States, Canada, Czech Republic, and Israel. The first participant was screened on 29 September 2010. The last participant observation was on 27 September 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Number screened: 222; randomized and treated (RAT; Safety Analysis Set): 81

Efficacy Analysis Set: 61 RAT participants with data for both end-of-period (EOP) scans, completed ≥ 7 consecutive days treatment in each period, took the morning dose before each EOP scan, and had baseline perfusion defect size ≥ 5% as measured by QPS imaging software.


Reporting Groups
  Description
Ranolazine/Placebo

Period 1: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise gated single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) study.

Period 2: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.

Placebo/Ranolazine

Period 1: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.

Period 2: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.


Participant Flow for 2 periods

Period 1:   Period 1
    Ranolazine/Placebo     Placebo/Ranolazine  
STARTED     41     40  
COMPLETED     39     38  
NOT COMPLETED     2     2  
Adverse Event                 2                 0  
Consent Withdrawal                 0                 1  
Significant Dosing Noncompliance                 0                 1  

Period 2:   Period 2
    Ranolazine/Placebo     Placebo/Ranolazine  
STARTED     39     39 [1]
COMPLETED     39     37  
NOT COMPLETED     0     2  
Adverse Event                 0                 2  
[1] 1 participant did not complete Period 1, but started and completed Period 2.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Analysis Set

Reporting Groups
  Description
All Participants

Baseline characteristics were analyzed as a single group (Safety Analysis Set). All participants were assigned to complete the same treatment periods in the same manner.

Ranolazine Treatment Period: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.

Placebo Treatment Period: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.


Baseline Measures
    All Participants  
Number of Participants  
[units: participants]
  81  
Age  
[units: years]
Mean ± Standard Deviation
  66  ± 9.0  
Age, Customized  
[units: participants]
 
18 to 39 years     0  
40 to 64 years     29  
65 to 74 years     39  
≥ 75 years     13  
Gender  
[units: participants]
 
Female     6  
Male     75  
Race/Ethnicity, Customized  
[units: participants]
 
White     72  
African-American     5  
Other     4  
Race/Ethnicity, Customized  
[units: participants]
 
Hispanic Or Latino     9  
Not Hispanic Or Latino     62  
Not Reported     5  
Unknown     5  
Region of Enrollment  
[units: participants]
 
United States     38  
Czech Republic     2  
Canada     27  
Israel     14  
Body mass index  
[units: kg/m^2]
Mean ± Standard Deviation
  29.6  ± 3.8  
Weight  
[units: kg]
Mean ± Standard Deviation
  88.6  ± 14.2  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Exercise-induced Perfusion Defect Size (PDS) Following Ranolazine and Placebo Treatment   [ Time Frame: Up to 33 days ]

2.  Primary:   Exercise-induced Total Perfusion Deficit (TPD) Following Ranolazine and Placebo Treatment   [ Time Frame: Up to 33 days ]

3.  Secondary:   Perfusion Defect Severity at Baseline, End of Period 1, and End of Period 2   [ Time Frame: Up to 33 days ]

4.  Secondary:   Exercise-induced Reversible Perfusion Defect Size (PDS) at Baseline, End of Period 1, and End of Period 2   [ Time Frame: Up to 33 days ]

5.  Secondary:   Exercise-induced Reversible Total Perfusion Deficit (TPD) at Baseline, End of Period 1, and End of Period 2   [ Time Frame: Up to 33 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences, Inc.
e-mail: ClinicalTrialDisclosures@gilead.com


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
Results First Received: July 1, 2014
Last Updated: August 21, 2014
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