Microvascular Coronary Disease In Women: Impact Of Ranolazine

Completed · Phase 2 · Has a placebo group

Conditions studied: Myocardial Ischemia

In brief

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).

Key facts

Study ID

NCT00570089

Run by

Cedars-Sinai Medical Center

People needed

20

Starts

2007-04-01

Expected to finish

2009-12-01

Last updated by the study team

2019-06-10

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• AHSP — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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