Impact of Ranolazine on Coronary Microcirculatory Resistance

Not Applicable

Completed

• Conditions: Coronary Artery Disease; Ischemia; Myocardial Disease; Coronary Microcirculation
• Interventions: Drug: Rnalozine

• Registration Number: NCT01815957
• Lead Sponsor: University of New Mexico

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2013-03-19
• Study First Submitted QC: 2013-03-19
• Study First Posted: 2013-03-21
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Results First Submitted: 2023-07-20
• Status Verified: 2023-12
• Results First Submitted QC: 2023-12-07
• Last Update Submitted: 2023-12-07
• Results First Posted: 2023-12-26
• Last Update Posted: 2023-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ranalozine	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Assessed for Relative Change in the Index of Microcirculatory Resistance Before and After Ranolazine Therapy	4 weeks

Trial Locations

Locations (1)

University of New Mexico Health Science Center; 🇺🇸 Albuquerque, New Mexico, United States