Ranolazine in Ischemic Cardiomyopathy

Tracking Information
First Submitted Date ICMJE	April 28, 2011
First Posted Date ICMJE	April 29, 2011
Results First Submitted Date	January 3, 2016
Results First Posted Date	September 6, 2018
Last Update Posted Date	September 6, 2018
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: August 5, 2018)	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.
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	Complete list of historical versions of study NCT01345188 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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	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	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	April 2014
Actual Primary Completion Date	April 2014 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: 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.; Anginal chest pain or dyspnea; Documentation of non treatable or optimally treated coronary artery disease; Ejection Fraction of less than or equal to 40% Exclusion Criteria: Less than 18 years of age; Pregnant or breast feeding; Patients with non ischemic cardiomyopathy
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	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	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	August 2018
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP