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Sodium Channel Blocker

Ranolazine for Myocardial Ischemia

Phase 2
Waitlist Available
Led By Noel Bairey-Merz, MD
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks and 10 weeks
Awards & highlights

Summary

To evaluate the impact of ranolazine extended-release tablets in women with subendocardial ischemia due to microvascular endothelial dysfunction on myocardial ischemia (Cardiac Magnetic Resonance (CMR) extent, severity. To evaluate the impact of ranolazine extended-release tablets in women with subendocardial ischemia due to microvascular endothelial dysfunction on the outcomes of angina (Seattle Angina Questionnaire (SAQ), WISE angina frequency, Duke Activity Status Inventory(DASI) and SF-36).

Eligible Conditions
  • Myocardial Ischemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks and 10 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks and 10 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cardiac Magnetic Resonance (CMRs)
Secondary outcome measures
Seattle Angina Questionnaire (SAQ)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Study Drug Ranexa, Then PlaceboExperimental Treatment2 Interventions
Participants first received study drug Ranexa, 500mg, orally twice daily for 2 weeks, assuming tolerance, followed by 1000mg orally twice daily for an additional 2 weeks. If the participant is unable to increase dose secondary to side effects, she will remain on 500mg twice daily for the second 2-week interval. After a washout period of 2 weeks, they then received Placebo tablet (matching Ranexa tablet).
Group II: Placebo, Then Study Drug Ranexa(Ranolazine)Experimental Treatment2 Interventions
Participants first received Placebo tablet (matching Ranexa tablet) for two weeks. After washout period of 2 weeks, they then received Ranexa 500mg, orally twice daily for 2 weeks, assuming tolerance, followed by 1000mg orally twice daily for an additional 2 weeks. If the participant is unable to increase dose secondary to side effects, she will remain on 500mg twice daily for the second 2-week interval.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ranolazine
FDA approved
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

CV TherapeuticsIndustry Sponsor
Cedars-Sinai Medical CenterLead Sponsor
504 Previous Clinical Trials
165,881 Total Patients Enrolled
13 Trials studying Myocardial Ischemia
14,734 Patients Enrolled for Myocardial Ischemia
Noel Bairey-Merz, MDPrincipal InvestigatorCedars-Sinai Medical Center
3 Previous Clinical Trials
443 Total Patients Enrolled
1 Trials studying Myocardial Ischemia
145 Patients Enrolled for Myocardial Ischemia
~1 spots leftby Sep 2025
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