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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

April 28, 2011
April 29, 2011
January 3, 2016
September 6, 2018
September 6, 2018
April 2011
April 2014   (Final data collection date for primary outcome measure)
  • 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
  • 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.
Improvement in symptoms with Ranexa assessed by Standardized Angina Questionnaire [ Time Frame: 12 weeks ]
Complete list of historical versions of study NCT01345188 on ClinicalTrials.gov Archive Site
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Ranolazine in Ischemic Cardiomyopathy
Ranolazine in Ischemic Cardiomyopathy Patients With Persistent Chest Pain or Dyspnea Despite Conventional Therapy: A Cross-Over Study
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.
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Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Cardiomyopathy
  • Chest Pain
  • Dyspnea
  • 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.
  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
60
April 2014
April 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01345188
IN-US-259-D032
Yes
Not Provided
Not Provided
Dr. Nicolas Shammas, Midwest Cardiovascular Research Foundation
Midwest Cardiovascular Research Foundation
Gilead Sciences
Principal Investigator: Nicolas W Shammas, MD Midwest Cardiovascular Research Foundation
Midwest Cardiovascular Research Foundation
August 2018

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