Ranolazine in Ischemic Cardiomyopathy
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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 : March 4, 2020
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Sponsor:
Midwest Cardiovascular Research Foundation
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Dr. Nicolas Shammas, Midwest Cardiovascular Research Foundation
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Tracking Information | ||||
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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 |
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Original Primary Outcome Measures ICMJE |
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 |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
28 | |||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |