Impact of Ranolazine on Coronary Microcirculatory Resistance

Coronary Artery Disease Clinical Trial

Official title:

Impact of Ranalozine on Coronary Microcirculatory Resistance- A Prospective Single Center Study to Evaluate the Effect of Ranalozine in Microcirculatory Resistance (MICRO Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01815957
• Other study ID #: 12-069 MICRO Study
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cardiomyopathies
• Coronary Artery Disease
• Coronary Disease
• Coronary Microcirculation
• Ischemia
• Myocardial Disease
• Myocardial Ischemia

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