Phase 4
N=28
Ranolazine in Ischemic Cardiomyopathy
Cardiomyopathy · Chest Pain · Dyspnea
Bottom Line
View on ClinicalTrials.gov: NCT01345188 ↗Enrolled (actual)
28
Serious AEs
4.2%
Results posted
Sep 2018
Primary outcome: Primary: Anginal Frequency — 86.67; 74.44 units on a scale — p=0.058
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ranexa (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Midwest Cardiovascular Research Foundation
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anginal Frequency |
86.67; 74.44 | 0.058 |
| PRIMARY Quality of Life Questionnaire |
72.22; 66.67 | 0.048 sig |
| PRIMARY Dyspnea Assessed by the Rose Dyspnea Questionnaire (RDQ) |
-0.45; -0.34 | >0.05 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01345188). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.