Coronary Artery Disease, Coronary Microcirculation, Ischemia, Myocardial Disease
Conditions
Keywords
coronary microcirculation, coronary artery disease, myocardial disease, ischemia
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 symptomatic improvement of chest pain during treatment with Ranalozine is related to improved coronary microcirculation function.
Interventions
DRUGRnalozine
. After enrollment in the study, participants will initiate Ranolazine for 4 weeks. The participant's usual anti-anginal medication regimen will be continued unchanged throughout study duration. Patients will receive Ranolazine 500 mg orally twice daily for 1 week, and the dose will be increased to 1,000 mg twice daily for an additional 3 weeks if tolerated.
Sponsors
Gilead Sciences
University of New Mexico
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \- 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 criteria
* \- 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Assessed for Relative Change in the Index of Microcirculatory Resistance Before and After Ranolazine Therapy | 4 weeks |
Countries
United States
Participant flow
Pre-assignment details
Publication: Title: Impact of ranolazine on coronary microvascular dysfunction (MICRO) study Published in Cardiovascular Revascularization Medicine: Volume 18, Issue 6, September 2017, Pages 431-435 Please refer to Table 1 for the Baseline Demographic Variables
Participants by arm
| Arm | Count |
|---|---|
| Ranalozine After enrollment in the study, participants will initiate Ranolazine for 4 weeks. The participant's usual anti-anginal medication regimen will be continued unchanged throughout study duration. Patients will receive Ranolazine 500 mg orally twice daily for 1 week, and the dose will be increased to 1,000 mg twice daily for an additional 3 weeks if tolerated.
Rnalozine: . After enrollment in the study, participants will initiate Ranolazine for 4 weeks. The participant's usual anti-anginal medication regimen will be continued unchanged throughout study duration. Patients will receive Ranolazine 500 mg orally twice daily for 1 week, and the dose will be increased to 1,000 mg twice daily for an additional 3 weeks if tolerated. | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | Ranalozine |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Age, Continuous | 57.6 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment United States | 7 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 7 |
| other Total, other adverse events | 0 / 7 | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 |
Outcome results
Primary
Number of Participants Assessed for Relative Change in the Index of Microcirculatory Resistance Before and After Ranolazine Therapy
Time frame: 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ranalozine | Number of Participants Assessed for Relative Change in the Index of Microcirculatory Resistance Before and After Ranolazine Therapy | 7 Participants |