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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01815957
Other study ID # 12-069 MICRO Study
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2012
Est. completion date March 2016

Study information

Verified date December 2023
Source University of New Mexico
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 7
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
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.

Locations

Country Name City State
United States University of New Mexico Health Science Center Albuquerque New Mexico

Sponsors (2)

Lead Sponsor Collaborator
University of New Mexico Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants Assessed for Relative Change in the Index of Microcirculatory Resistance Before and After Ranolazine Therapy 4 weeks
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