Impact of Ranolazine on Coronary Microcirculatory Resistance

NCT01815957 | Completed Results

• 1 other identifier: 12-069 MICRO Study
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Microcirculation; Coronary Artery Disease; Myocardial Disease; Ischemia

Keywords

coronary microcirculation; coronary artery disease; myocardial disease; ischemia

Outcome Measures

Primary Outcomes (1)

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

  4 weeks

Study Arms (1)

Ranalozine

EXPERIMENTAL

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.

Drug: Rnalozine

Interventions

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.

Also known as: Ranexa, Ranalozine

Ranalozine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University of New Mexico: lead
• Gilead Sciences: collaborator

Study Sites (1)

University of New Mexico Health Science Center

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Cardiomyopathies; Ischemia

Interventions

Ranolazine

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Bina Ahmed
• Organization: UNewMexico

hkhawaja@salud.unm.edu

505-272-7028

Study Officials

• Bina Ahmed, MD

  Assistant Professor, IM Div Cardiology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2013
• First Posted: March 21, 2013
• Study Start: May 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: December 26, 2023
• Results First Posted: December 26, 2023

Record last verified: 2023-12

Locations

US (1)