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Treatment With Ranolazine in Microvascular Coronary Dysfunction (MCD): Impact on Angina Myocardial Ischemia (RWISE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01342029
First Posted: April 26, 2011
Last Update Posted: December 12, 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.
Collaborator:
University of Florida
Information provided by (Responsible Party):
Noel Bairey Merz, Cedars-Sinai Medical Center
Results First Submitted: April 21, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Microvascular Coronary Dysfunction (MCD)
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
No text entered.

Reporting Groups
  Description
Ranolazine First, Then Placebo

147 subjects, with projected 9-10% dropout and anticipated 134 completed subjects will undergo baseline testing and then be randomized into a clinical cross-over trial of stepped dosing of ranolazine or placebo 500-1,000 mg po bid for 2 weeks with exit testing followed by cross-over to the alternate ranolazine or placebo and repeat exit testing.

Ranolazine: This drug is approved by the U.S. Food and Drug Administration (FDA) for treatment of chronic angina.

500-1,000 mg po bid for 2 weeks

Placebo First, Then Ranolazine

147 subjects, with projected 9-10% dropout and anticipated 134 completed subjects will undergo baseline testing and then be randomized into a clinical cross-over trial of stepped dosing of ranolazine or placebo 500-1,000 mg po bid for 2 weeks with exit testing followed by cross-over to the alternate ranolazine or placebo and repeat exit testing.

Placebo: 500-1,000 mg po bid for 2 weeks


Participant Flow for 3 periods

Period 1:   Period 1
    Ranolazine First, Then Placebo   Placebo First, Then Ranolazine
STARTED   70   72 
Dropout   3   1 
COMPLETED   67   71 
NOT COMPLETED   3   1 

Period 2:   Washout
    Ranolazine First, Then Placebo   Placebo First, Then Ranolazine
STARTED   67   71 
COMPLETED   67   67 
NOT COMPLETED   0   4 

Period 3:   Period 2
    Ranolazine First, Then Placebo   Placebo First, Then Ranolazine
STARTED   67   67 
Dropout   2   0 
COMPLETED   65   67 
NOT COMPLETED   2   0 



  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.
Total 10 dropout (4 dropout during period 1, 4 dropout during washout, 2 dropout during period 2)

Reporting Groups
  Description
Ranolazine/Placebo

147 subjects will be enrolled at two clinical sites, with projected 9-10% dropout and anticipated 134 completed subjects.

For Ranolazine first group, subjects will undergo baseline testing and then be randomized into a clinical cross-over trial of stepped dosing of ranolazine or placebo 500-1,000 mg po bid for 2 weeks with exit testing followed by cross-over to the alternate ranolazine or placebo and repeat exit testing.

For Placebo first group, subjects will undergo baseline testing and then be randomized into a clinical cross-over trial of stepped dosing of ranolazine or placebo 500-1,000 mg po bid for 2 weeks with exit testing followed by cross-over to the alternate ranolazine or placebo and repeat exit testing.


Baseline Measures
   Ranolazine/Placebo 
Overall Participants Analyzed 
[Units: Participants]
 142 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      142 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.2  (9.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      135  95.1% 
Male      7   4.9% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   142 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Seattle Angina Questionnaire (SAQ)   [ Time Frame: 2 weeks (first intervention) and 6 weeks (second intervention) ]

2.  Secondary:   Cardiac Magnetic Resonance (CMRs)   [ Time Frame: 2 weeks (first intervention) and 6 weeks (second intervention) ]


  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 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: C.Noel Bairey Merz, MD
Organization: Cedars-Sinai Medical Center
phone: 310-423-9680
e-mail: merz@cshs.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Noel Bairey Merz, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT01342029     History of Changes
Other Study ID Numbers: IN-US-259-0124 - RWISE
First Submitted: April 22, 2011
First Posted: April 26, 2011
Results First Submitted: April 21, 2017
Results First Posted: December 12, 2017
Last Update Posted: December 12, 2017