Ranolazine in Ischemic Cardiomyopathy

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

Tracking Information

• First Submitted Date: April 28, 2011
• First Posted Date: April 29, 2011
• Results First Submitted Date: January 3, 2016
• Results First Posted Date: September 6, 2018
• Last Update Posted Date: March 4, 2020
• Study Start Date: April 2011
• Actual Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: April 28, 2011): Improvement in symptoms with Ranexa assessed by Standardized Angina Questionnaire [ Time Frame: 12 weeks ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Ranolazine in Ischemic Cardiomyopathy
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment

Condition

• Cardiomyopathy
• Chest Pain
• Dyspnea

Intervention

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 24, 2014): 28
• Original Estimated Enrollment (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

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01345188
• Other Study ID Numbers: 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: Midwest Cardiovascular Research Foundation
• Collaborators: Gilead Sciences

Investigators

• Principal Investigator: Nicolas W Shammas, MD; Midwest Cardiovascular Research Foundation

• PRS Account: Midwest Cardiovascular Research Foundation
• Verification Date: February 2020