Microvascular Coronary Disease In Women: Impact Of Ranolazine
Myocardial Ischemia
About this trial
This is an interventional treatment trial for Myocardial Ischemia focused on measuring Ranolazine, Myocardial ischemia, Double blinded, Placebo controlled
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.
Sites / Locations
- AHSP
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Study Drug Ranexa, Then Placebo
Placebo, Then Study Drug Ranexa(Ranolazine)
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).
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.