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Effects of Ranolazine on Coronary Flow Reserve in Symptomatic Diabetic Patients and CAD (RAND-CFR)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01754259
First Posted: December 21, 2012
Last Update Posted: July 24, 2017
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):
Marcelo F. Di Carli, MD, FACC, Brigham and Women's Hospital
Results First Submitted: March 23, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Other
Conditions: Diabetes, Type I
Diabetes, Type II
Angina
Coronary Artery Disease
Interventions: Drug: Ranolazine
Drug: Placebo

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The order of ranolazine and placebo exposure was randomly assigned in a 1:1 ratio by the Investigational Drug Service at BWH. During the 28-day treatment periods, ranolazine and matching placebo were administered as 500 mg by mouth twice daily for 1 week and increased to 1000 mg by mouth twice daily for 3 weeks, as tolerated.

Reporting Groups
  Description
Ranolazine

subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.

Ranolazine: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.

Placebo

Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.

Placebo Pill: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.


Participant Flow:   Overall Study
    Ranolazine   Placebo
STARTED   23   24 
COMPLETED   18   18 
NOT COMPLETED   5   6 
Withdrawal by Subject                2                4 
Adverse Event                3                1 
Lost to Follow-up                0                1 



  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.
No text entered.

Reporting Groups
  Description
Ranolazine

subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.

Ranolazine: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.

Placebo

Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.

Placebo Pill: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.

Total Total of all reporting groups

Baseline Measures
   Ranolazine   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 23   24   47 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      7  30.4%      12  50.0%      19  40.4% 
>=65 years      16  69.6%      12  50.0%      28  59.6% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      11  47.8%      13  54.2%      24  51.1% 
Male      12  52.2%      11  45.8%      23  48.9% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Caucasian   16   18   34 
Black   4   6   10 
Asian   2   0   2 
Indian   1   0   1 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   23   24   47 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Post-exercise Coronary Vasodilator Reserve   [ Time Frame: 4 weeks ]

2.  Secondary:   Change in LV Diastolic Function   [ Time Frame: 4 weeks ]


  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
The limitations for our study include a relatively small cohort size of 47 patients, that our mechanistic trial was not designed to assess clinical outcomes and that our experimental design allowed for inclusion of patients with non-obstructive CAD.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Dr. Marcelo Di Carli
Organization: Brigham and Women's Hospital
phone: 617-732-6291
e-mail: mdicarli@partners.org



Responsible Party: Marcelo F. Di Carli, MD, FACC, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01754259     History of Changes
Other Study ID Numbers: 2012P002537
First Submitted: December 12, 2012
First Posted: December 21, 2012
Results First Submitted: March 23, 2017
Results First Posted: July 24, 2017
Last Update Posted: July 24, 2017