Impact of Ranolazine on Coronary Microcirculatory Resistance

Sponsor

University of New Mexico (Other)

Overall Status

Unknown status

CT.gov ID

NCT01815957

Collaborator

Gilead Sciences (Industry)

Enrollment

Location

Arm

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Microcirculation Coronary Artery Disease Myocardial Disease Ischemia	Drug: Rnalozine	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Study Start Date :

May 1, 2012

Anticipated Primary Completion Date :

Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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. Other Names: Ranexa Ranalozine

Arm

Intervention/Treatment

Experimental: 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.

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.

Other Names:

Ranexa

Ranalozine

Outcome Measures

Primary Outcome Measures

Relative change in IMR before and after Ranolazine therapy. [4 weeks]
Relative change in IMR before and after Ranolazine therapy. Mean change between the groups will be analyzed using a paired t test.

Secondary Outcome Measures

Absolute change in SAQ and DASI scores before and after Ranolazine therapy. [4 weeks]
Absolute change in SAQ and DASI scores before and after Ranolazine therapy. Mean change between the groups will be analyzed using a paired t test.
Compare relative change in IMR among patients with and without symptomatic improvement in angina burden based on SAQ and DASI scores. [4 weeks]
Compare relative change in IMR among patients with and without symptomatic improvement in angina burden based on SAQ and DASI scores.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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