N/A
N=7
Impact of Ranolazine on Coronary Microcirculatory Resistance
Coronary Microcirculation · Coronary Artery Disease · Myocardial Disease · Ischemia
Bottom Line
View on ClinicalTrials.gov: NCT01815957 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Number of Participants Assessed for Relative Change in the Index of Microcirculatory Resistance Before and After Ranolazine Therapy — 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Rnalozine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of New Mexico
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Assessed for Relative Change in the Index of Microcirculatory Resistance Before and After Ranolazine Therapy |
7 | — |
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 symptomatic improvement of chest pain during treatment with Ranalozine is related to improved coronary microcirculation function.
Eligibility Criteria
Inclusion Criteria
- - Patients with subjective symptoms of ischemia without flow limiting angiographic CAD ( 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 Criteria
- - Age 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
Data sourced from ClinicalTrials.gov (NCT01815957). 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.