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Ranolazine in Ischemic Cardiomyopathy

NCT ID: NCT01345188

Last Updated: 2024-12-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2014-04-30

Brief Summary

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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

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Conditions

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Cardiomyopathy Chest Pain Dyspnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Ranolazine

1000 mg Ranexa orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.

Group Type ACTIVE_COMPARATOR

Ranexa

Intervention Type DRUG

1000 mg Ranexa orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.

Placebo

1000 mg placebo orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1000 mg placebo orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.

Interventions

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Ranexa

1000 mg Ranexa orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.

Intervention Type DRUG

Placebo

1000 mg placebo orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.

Intervention Type DRUG

Other Intervention Names

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Ranolazine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role collaborator

Midwest Cardiovascular Research Foundation

OTHER

Sponsor Role lead

Responsible Party

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Dr. Nicolas Shammas

Principal Investigator, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nicolas W Shammas, MD

Role: PRINCIPAL_INVESTIGATOR

Midwest Cardiovascular Research Foundation

Locations

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Midwest Cardiovascular Research Foundation

Davenport, Iowa, United States

Site Status

Countries

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United States

Other Identifiers

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IN-US-259-D032

Identifier Type: -

Identifier Source: org_study_id