ClinicalTrials.gov
ClinicalTrials.gov Menu

Ranolazine in Ischemic Cardiomyopathy

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.
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
Enrollment 28
Recruitment Details Participants recruited from a cardiovascular clinic in Davenport, Iowa between 5/21/2012 and 11/22/2013
Pre-assignment Details 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.
Arm/Group Title Ranolazine, Then Placebo
Hide Arm/Group Description 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.
Period Title: Randomization Ranolazine/Placebo 6 Weeks
Started 28
Completed 26
Not Completed 2
Reason Not Completed
Withdrawal by Subject             2
Period Title: Crossover Ranolazine/Placebo 6 Weeks
Started 26
Completed 25
Not Completed 1
Reason Not Completed
Lost to Follow-up             1
Arm/Group Title Entire Study Population
Hide Arm/Group Description Includes both groups randomized to placebo and ranolazine
Overall Number of Baseline Participants 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants
71.5  (8.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Female
5
  17.9%
Male
23
  82.1%
Ejection Fraction  
Mean (Standard Deviation)
Unit of measure:  Percentage
Number Analyzed 28 participants
33.1  (7.6)
Diabetes Mellitus  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 28 participants
19
Prior myocardial infarction  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 28 participants
23
1.Primary Outcome
Title Anginal Frequency
Hide Description Anginal frequency as assessed by Seattle Angina Questionnaire. Scoring is done by assessing responses on an ordinal value. Anginal score is scored by the patient by selecting a number from 0 to 100 with low score indicates more anginal frequency. The mean of the the scores of all patients analyzed were compared between placebo and Ranolazine.
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients receiving ranolazine for 6 weeks and crossed over to placebo or vice versa. Higher number on the angina scale indicates less angina
Arm/Group Title Ranolazine Placebo
Hide Arm/Group Description:
[Not Specified]
Patients that received placebo
Overall Number of Participants Analyzed 24 24
Mean (Full Range)
Unit of Measure: units on a scale
86.67
(40 to 100)
74.44
(10 to 100)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ranolazine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.058
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
2.Primary Outcome
Title Quality of Life
Hide Description Quality of life as measured by the Seattle Angina Questionnaire as a score ranging from 0 to 100. Higher score indicates better quality of life. The Qaulity of life is scored by the patient
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ranolazine Placebo
Hide Arm/Group Description:
Patients that received ranolazine
Patients that received placebo
Overall Number of Participants Analyzed 24 24
Mean (Full Range)
Unit of Measure: units on a scale
72.22
(50 to 92)
66.67
(42 to 92)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ranolazine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.048
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
3.Primary Outcome
Title Dyspnea Assessed by the Rose Dyspnea Questionnaire (RDQ)
Hide Description RDQ is a four item questionnaire that evaluates a patient's dyspnea with regular activity. Each question answered postiviely is given a score of 1. Total score possible is 4. A higher score indicates worse dyspnea. A difference between the score at end of treatment minus baseline is performed. A negative score indicates improvement. Comparing the difference between the 2 arms (placebo and ranolazine) is performed.
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients with dsypnea. The score reflects difference between baseline and following treatment with ranolazine or placebo
Arm/Group Title Ranolazine Placebo
Hide Arm/Group Description:
Patients that received ranolazine
Patients that received placebo
Overall Number of Participants Analyzed 20 20
Mean (Full Range)
Unit of Measure: units on a scale
-0.45
(-4 to 2)
-0.34
(-2 to 1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ranolazine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Wilcoxon Signed rank
Comments [Not Specified]
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ranolazine Placebo
Hide Arm/Group Description patients receiving ranolazine Patients receiving placebo
All-Cause Mortality
Ranolazine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)      0/24 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Ranolazine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/24 (8.33%)      0/24 (0.00%)    
Cardiac disorders     
Heart failure  [1]  1/24 (4.17%)  1 0/24 (0.00%)  0
Nervous system disorders     
stroke  [2]  1/24 (4.17%)  1 0/24 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
patient was admitted to the hospital with exacerbation of his heart failure, but this patient also had pneumonia and sepsis.study drug.
[2]
From atrial fibrillation. Unrelated to study medication
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ranolazine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/24 (25.00%)      2/24 (8.33%)    
Gastrointestinal disorders     
Nausea  [1]  2/24 (8.33%)  2 0/24 (0.00%)  0
constipation   2/24 (8.33%)  2 0/24 (0.00%)  0
Nervous system disorders     
diziness  [2]  3/24 (12.50%)  3 2/24 (8.33%)  2
Indicates events were collected by systematic assessment
[1]
Intolerance to high dose of medication
[2]
Intolerance to medication
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
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