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Ranolazine in Ischemic Cardiomyopathy

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ClinicalTrials.gov Identifier: NCT01345188
Recruitment Status : Completed
First Posted : April 29, 2011
Results First Posted : September 6, 2018
Last Update Posted : September 6, 2018
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Dr. Nicolas Shammas, Midwest Cardiovascular Research Foundation

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions: Cardiomyopathy
Chest Pain
Dyspnea
Interventions: Drug: Ranexa
Drug: Placebo

  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 recruited from a cardiovascular clinic in Davenport, Iowa between 5/21/2012 and 11/22/2013

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 36 patients assessed for eligibility. Excluded were 8 patients (did not meet inclusion criteria=4; declined to participate=3;other=1). 28 patients were included in this randomized cross-over study.

Reporting Groups
  Description
Ranolazine, Then Placebo Patient received Ranolazine to 1,000 mg ranolazine orally twice a day, as tolerated for 6 weeks. After a washout period of 2 weeks, they then received Placebo tablet (matching Ranolazine 1000 mg tablet twice a week) for 6 weeks.

Participant Flow for 2 periods

Period 1:   Randomization Ranolazine/Placebo 6 Weeks
    Ranolazine, Then Placebo
STARTED   28 
COMPLETED   26 
NOT COMPLETED   2 
Withdrawal by Subject                2 

Period 2:   Crossover Ranolazine/Placebo 6 Weeks
    Ranolazine, Then Placebo
STARTED   26 
COMPLETED   25 
NOT COMPLETED   1 
Lost to Follow-up                1 



  Baseline Characteristics

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
Entire Study Population Includes both groups randomized to placebo and ranolazine

Baseline Measures
   Entire Study Population 
Overall Participants Analyzed 
[Units: Participants]
 28 
Age 
[Units: Years]
Mean (Standard Deviation)
 71.5  (8.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      5  17.9% 
Male      23  82.1% 
Ejection Fraction 
[Units: Percentage]
Mean (Standard Deviation)
 33.1  (7.6) 
Diabetes Mellitus 
[Units: Participants]
 19 
Prior myocardial infarction 
[Units: Participants]
 23 


  Outcome Measures

1.  Primary:   Anginal Frequency   [ Time Frame: 12 weeks ]

2.  Primary:   Quality of Life   [ Time Frame: 12 weeks ]

3.  Primary:   Dyspnea Assessed by the Rose Dyspnea Questionnaire (RDQ)   [ Time Frame: 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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 Nicolas W Shammas
Organization: Midwest Cardiovascular Research Foundation
phone: 5633242828
e-mail: shammas@mchsi.com



Responsible Party: Dr. Nicolas Shammas, Midwest Cardiovascular Research Foundation
ClinicalTrials.gov Identifier: NCT01345188     History of Changes
Other Study ID Numbers: IN-US-259-D032
First Submitted: April 28, 2011
First Posted: April 29, 2011
Results First Submitted: January 3, 2016
Results First Posted: September 6, 2018
Last Update Posted: September 6, 2018