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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01221272
First Posted: October 14, 2010
Last Update Posted: September 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gilead Sciences
Results First Submitted: July 1, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, 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
  Hide Participant Flow

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 
Overall Participants Analyzed 
[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



Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01221272     History of Changes
Other Study ID Numbers: GS-US-259-0103
First Submitted: October 13, 2010
First Posted: October 14, 2010
Results First Submitted: July 1, 2014
Results First Posted: September 3, 2014
Last Update Posted: September 3, 2014