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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 November 2012 |
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Main ID: |
NCT01345188 |
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Date of registration:
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28/04/2011 |
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Primary sponsor: |
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Public title:
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Ranolazine in Ischemic Cardiomyopathy Patients With Persistent Chest Pain or Dyspnea Despite Conventional Therapy: A Cross-Over Study
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Scientific title:
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Ranolazine in Ischemic Cardiomyopathy Patients With Persistent Chest Pain or Dyspnea Despite Conventional Therapy: A Cross-Over Study |
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Date of first enrolment:
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April 2011 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01345188 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Nicolas W Shammas, MD |
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Address:
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Telephone:
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563-320-0263 |
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Email:
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shammas@mchsi.com |
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Affiliation:
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Name:
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Nicolas W Shammas, MD |
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Address:
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Telephone:
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(563) 320-0263 |
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Email:
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shammas@mchsi.com |
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Affiliation:
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Name:
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Nicolas W Shammas, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Midwest Cardiovascular Research Foundation |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cardiomyopathy
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Chest Pain
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Dyspnea
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Intervention(s)
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Drug: Placebo
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Drug: Ranexa
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Primary Outcome(s)
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Combined endpoint of improvement in chest pain symptoms with Ranexa assessed by Standardized Angina Questionnaire or dyspnea using the Rose Dyspnea Scale (RDS)Questionnaire
[Time Frame: 12 weeks]
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Secondary ID(s)
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IN-US-259-D032
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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