Status:
COMPLETED
Impact of Ranolazine on Coronary Microcirculatory Resistance
Lead Sponsor:
University of New Mexico
Collaborating Sponsors:
Gilead Sciences
Conditions:
Coronary Microcirculation
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is being done to determine if Ranolazine treatment improves coronary microcirculation function among patients with coronary microcirculation dysfunction. We are also looking to learn if sym...
Eligibility Criteria
Inclusion
- \- Patients with subjective symptoms of ischemia without flow limiting angiographic CAD (\<50% epicardial coronary stenosis) and abnormal IMR (\>20 U).
- Definition of ischemia (any one):
- chest pain with dynamic ischemic ECG changes (t wave inversions or \> 1 mm ST depressions
- Exercise treadmill testing induced chest pain with ≥1 mm of downsloping or flat ST segment depression during exercise or recovery; ≥2 mm of ischemic ST depression at a low workload (stage 2 or less or ≤130 beats/min); early onset (stage 1) or prolonged duration (\>5 min) of ST depression; multiple leads (\>5) with ST depression
- Nuclear stress perfusion defect \> 10%
- Stress echocardiogram with stress induced wall motion abnormality
Exclusion
- \- Age \< 18 yrs
- Flow Limiting epicardial CAD \>50%
- Life expectancy \< 6 months
- Recent (\<1 week) myocardial infarction or positive biomarkers
- Severe aortic stenosis
- Contraindications to IMR testing including inability to utilize antithrombotic therapy and/or intravenous adenosine
- Contraindications to Ranolazine therapy:
- Patients with known hepatic insufficiency, prolonged QT or renal failure (GFR \< 60)
- use of drugs that inhibit CYP3A such as diltiazem, verapamil, ketoconazole, macrolides and HIV protease inhibitors
- Pregnancy, breastfeeding
- Patients taking drugs which prolong QT interval
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01815957
Start Date
May 1 2012
End Date
March 1 2016
Last Update
December 26 2023
Active Locations (1)
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1
University of New Mexico Health Science Center
Albuquerque, New Mexico, United States, 87131