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Ranolazine in Ischemic Cardiomyopathy

This study has been completed.
Sponsor:
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
  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
Intervention Model: Crossover Assignment
Masking: Double Blind (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

Resource links provided by NLM:


Further study details as provided by Dr. Nicolas Shammas, 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 ]

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)
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
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

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

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 July 25, 2017