N/A
N=142
Treatment With Ranolazine in Microvascular Coronary Dysfunction (MCD): Impact on Angina Myocardial Ischemia
Microvascular Coronary Dysfunction (MCD)
Bottom Line
View on ClinicalTrials.gov: NCT01342029 ↗Enrolled (actual)
142
Serious AEs
2.5%
Results posted
Dec 2017
Primary outcome: Primary: Seattle Angina Questionnaire (SAQ) — 68.09; 66.7; 58.4; 51.17 Units on scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ranolazine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cedars-Sinai Medical Center
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Seattle Angina Questionnaire (SAQ) |
68.09; 66.7; 58.4; 51.17; 63.91; 62.73 | — |
| SECONDARY Cardiac Magnetic Resonance (CMRs) |
1.98; 1.96 | — |
Summary
This research study is designed to test the use of ranolazine in patients with angina (chest discomfort due to reduced blood supply to the heart) due to microvascular coronary dysfunction (MCD; abnormalities in the small blood vessels of the heart). This drug is approved by the U.S. Food and Drug Administration (FDA) for treatment of chronic angina. The FDA has approved this drug based on studies primarily on patients with chronic angina with major blockages of the arteries.
Eligibility Criteria
Inclusion Criteria
- Men or women age >18 from diverse racial/ethnic groups;
- Competent to give informed consent;
- Patients with chronic angina or its equivalent;
- Coronary angiogram revealing MCD with no obstructive CAD (epicardial coronary stenosis or = 45%;
- Objective evidence of ischemia by noninvasive methods such as exercise stress test, stress Echo, MRI, or SPECT;
- Patients with 10% myocardial ischemia by Cardiac magnetic resonance imaging (CMRI) myocardial perfusion reserve index ≤ 2.0 or abnormal coronary reactivity testing (CFR 160/95mmHg with measurements recorded on at least 2 occasions), conditions likely to influence outcomes: Severe lung, creatinine >1.8 or CrCl ≤ 50ml/min) or hepatic disease;
- Surgically uncorrected significant congenital or valvular heart disease and other disease likely to be fatal or require frequent hospitalization within the next six months;
- Adherence or retention reasons;
- Unwilling to complete follow-up evaluation including repeat testing, documented obstructive hypertrophic cardiomyopathy;
- Aortic stenosis (valve area <1.5cm);
- LV dysfunction (ejection fraction ≤35%);
- History of significant cocaine or amphetamine abuse;
- Taking potent CYP3A4 inhibitors (ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir);
- Women who are pregnant.
Data sourced from ClinicalTrials.gov (NCT01342029). 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.