Impact of Ranolazine on Coronary Microcirculatory Resistance

NCT ID: NCT01815957

Last Updated: 2023-12-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2016-03-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ranalozine

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.

Group Type: EXPERIMENTAL

Rnalozine

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Ranexa; Ranalozine

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: collaborator

University of New Mexico

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bina Ahmed, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor, IM Div Cardiology

Locations

University of New Mexico Health Science Center

Albuquerque, New Mexico, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

12-069 MICRO Study

Identifier Type: -

Identifier Source: org_study_id