Phase 2
N=20
Microvascular Coronary Disease In Women: Impact Of Ranolazine
Myocardial Ischemia
Bottom Line
View on ClinicalTrials.gov: NCT00570089 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcome: Primary: Cardiac Magnetic Resonance (CMRs) — 11.7; 16.0 Percentage of ischemic myocardium
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ranolazine (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- Cedars-Sinai Medical Center
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cardiac Magnetic Resonance (CMRs) |
11.7; 16.0 | — |
| SECONDARY Seattle Angina Questionnaire (SAQ) |
91.7; 83.3; 75; 50; 80; 75 | — |
Summary
1. 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.
2. 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).
Eligibility Criteria
Inclusion Criteria
- Women with signs and symptoms of myocardial ischemia (chest pain, abnormal stress testing, abnormal noninvasive testing) in the absence of obstructive coronary artery disease (epicardial coronary stenosis <50% luminal diameter stenosis).
- Women with ≥10% myocardial ischemia by CMR perfusion.
Exclusion Criteria
- Contraindications to withholding nitrates, beta-blockers, calcium channel agents, ACE/ARB agents for 48 hours prior to testing.
- Contraindications in CMR including AICD, pacemaker, untreatable claustrophobia or known angio-edema.
- Contraindications to ranolazine including hepatic insufficiency, prolonged QT, renal failure.
- Women taking drugs that inhibit CYP3A such as diltiazem, verapamil, ketoconazole, macrolides or HIV protease inhibitors.
- Women less than 18 years of age.
- Women on drugs that prolong the QT interval such as Class Ia or III antiarrhythmic agents, erythromycin, certain antipsychotics.
- Pregnancy or breast feeding.
- Life expectancy less than 6 months.
Data sourced from ClinicalTrials.gov (NCT00570089). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.