Ranolazine in Ischemic Cardiomyopathy
This study has been completed.
Sponsor:
Midwest Cardiovascular Research Foundation
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Dr. Nicolas Shammas, Midwest Cardiovascular Research Foundation
ClinicalTrials.gov Identifier:
NCT01345188
First received: April 28, 2011
Last updated: September 24, 2014
Last verified: September 2014
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cardiomyopathy Chest Pain Dyspnea |
Drug: Ranexa Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Ranolazine in Ischemic Cardiomyopathy Patients With Persistent Chest Pain or Dyspnea Despite Conventional Therapy: A Cross-Over Study |
Resource links provided by NLM:
Further study details as provided by Midwest Cardiovascular Research Foundation:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
| Enrollment: | 28 |
| Study Start Date: | April 2011 |
| Study Completion Date: | April 2014 |
| Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Ranolazine
1000 mg Ranexa orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.
|
Drug: Ranexa
1000 mg Ranexa orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.
Other Name: Ranolazine
|
|
Placebo Comparator: Placebo
1000 mg placebo orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.
|
Drug: Placebo
1000 mg placebo orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01345188
Please refer to this study by its ClinicalTrials.gov identifier: NCT01345188
Locations
| United States, Iowa | |
| Midwest Cardiovascular Research Foundation | |
| Davenport, Iowa, United States, 52803 | |
Sponsors and Collaborators
Midwest Cardiovascular Research Foundation
Gilead Sciences
Investigators
| Principal Investigator: | Nicolas W Shammas, MD | Midwest Cardiovascular Research Foundation |
More Information
| Responsible Party: | Dr. Nicolas Shammas, Principal Investigator, MD, Midwest Cardiovascular Research Foundation |
| ClinicalTrials.gov Identifier: | NCT01345188 History of Changes |
| Other Study ID Numbers: | IN-US-259-D032 |
| Study First Received: | April 28, 2011 |
| Last Updated: | September 24, 2014 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Cardiomyopathies Dyspnea Chest Pain Heart Diseases Cardiovascular Diseases Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Pain Neurologic Manifestations Nervous System Diseases Ranolazine Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 23, 2016