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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 : March 4, 2020
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Dr. Nicolas Shammas, Midwest Cardiovascular Research Foundation

Tracking Information
First Submitted Date  ICMJE April 28, 2011
First Posted Date  ICMJE April 29, 2011
Results First Submitted Date  ICMJE January 3, 2016
Results First Posted Date  ICMJE September 6, 2018
Last Update Posted Date March 4, 2020
Study Start Date  ICMJE April 2011
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2020)
  • Anginal Frequency [ Time Frame: 12 weeks ]
    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.
  • Quality of Life [ Time Frame: 12 weeks ]
    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. It assesses the perceived satisfaction or dissatisfaction in the major domains of life. These include mobility, self-care, Usual activities (leisure, work, family), Pain/Discomfort, and Anxiety.
  • Dyspnea Assessed by the Rose Dyspnea Questionnaire (RDQ) [ Time Frame: 12 weeks ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 28, 2011)
Improvement in symptoms with Ranexa assessed by Standardized Angina Questionnaire [ Time Frame: 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ranolazine in Ischemic Cardiomyopathy
Official Title  ICMJE Ranolazine in Ischemic Cardiomyopathy Patients With Persistent Chest Pain or Dyspnea Despite Conventional Therapy: A Cross-Over Study
Brief Summary Patients with ischemic cardiomyopathy may continue to experience persistent chest pain and shortness of breath despite conventional medical therapy and/or revascularization. The purpose of this study is to determine the efficacy of taking Ranexa versus placebo in patients with ischemic (due to blockages) cardiomyopathy treated with optimal conventional medical therapy and/or percutaneous revascularization.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Cardiomyopathy
  • Chest Pain
  • Dyspnea
Intervention  ICMJE
  • Drug: Ranexa
    1000 mg Ranexa orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.
    Other Name: Ranolazine
  • Drug: Placebo
    1000 mg placebo orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.
Study Arms  ICMJE
  • Active Comparator: Ranolazine
    1000 mg Ranexa orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.
    Intervention: Drug: Ranexa
  • Placebo Comparator: Placebo
    1000 mg placebo orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 24, 2014)
28
Original Estimated Enrollment  ICMJE
 (submitted: April 28, 2011)
60
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Ischemic cardiomyopathy patients on optimal medical treatment. Optimal medical treatment is defined as the continued symptoms of chest pain or dyspnea despite treatment with 2 antiischemic agents (beta blockers, CCB or nitrates). Unless contraindicated, all cardiomyopathy patients should be treated with a beta blocker and an ACEI/ARB.
  2. Anginal chest pain or dyspnea
  3. Documentation of non treatable or optimally treated coronary artery disease
  4. Ejection Fraction of less than or equal to 40%

Exclusion Criteria:

  1. Less than 18 years of age
  2. Pregnant or breast feeding
  3. Patients with non ischemic cardiomyopathy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01345188
Other Study ID Numbers  ICMJE IN-US-259-D032
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Nicolas Shammas, Midwest Cardiovascular Research Foundation
Study Sponsor  ICMJE Midwest Cardiovascular Research Foundation
Collaborators  ICMJE Gilead Sciences
Investigators  ICMJE
Principal Investigator: Nicolas W Shammas, MD Midwest Cardiovascular Research Foundation
PRS Account Midwest Cardiovascular Research Foundation
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP