Skip to main content
OpenTrials
Completed

NCT Number: NCT01815957

Impact of Ranolazine on Coronary Microcirculatory Resistance

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of New Mexico Health Science Center

Albuquerque, New Mexico, 87131, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rnalozine

Drug

. 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.

Other names: Ranexa, Ranalozine

Primary outcomes

  1. Number of Participants Assessed for Relative Change in the Index of Microcirculatory Resistance Before and After Ranolazine Therapy

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Collaborators

  • Gilead Sciences

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Mar 21, 2013
Registry last updated
Dec 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.