ClinicalTrials.gov
ClinicalTrials.gov Menu

Ranolazine in Ischemic Cardiomyopathy

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
Last Update Posted : September 25, 2014
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Dr. Nicolas Shammas, Midwest Cardiovascular Research Foundation

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Cardiomyopathy Chest Pain Dyspnea Drug: Ranexa Drug: Placebo Phase 4

Study Design
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Ranolazine in Ischemic Cardiomyopathy Patients With Persistent Chest Pain or Dyspnea Despite Conventional Therapy: A Cross-Over Study
Study Start Date : April 2011
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Ranolazine
U.S. FDA Resources

Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.


Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: April 29, 2011    Key Record Dates
Last Update Posted: September 25, 2014
Last Verified: September 2014

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