Impact of Ranolazine on Coronary Microcirculatory Resistance

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by University of New Mexico
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Bina Ahmed, University of New Mexico
ClinicalTrials.gov Identifier:
NCT01815957
First received: March 19, 2013
Last updated: NA
Last verified: March 2013
History: No changes posted
  Purpose

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 Intervention
Coronary Microcirculation
Coronary Artery Disease
Myocardial Disease
Ischemia
Drug: Rnalozine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • Relative change in IMR before and after Ranolazine therapy. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Compare relative change in IMR among patients with and without symptomatic improvement in angina burden based on SAQ and DASI scores.


Estimated Enrollment: 20
Study Start Date: May 2012
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01815957

Contacts
Contact: Bina Ahmed, MD 505-272-2273 BAhmed@Salud.unm.edu
Contact: Lyra Salandre, BA 505-272-9898 LAsalandre@salud.unm.edu

Locations
United States, New Mexico
University of New Mexico Health Science Center Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Bina Ahmed, MD    505-272-2273    BAhmed@Salud.unm.edu   
Contact: Lyra Salandre, BA    505-272-9898    LSalandre@Salud.unm.edu   
Principal Investigator: Bina Ahmed, MD         
Sponsors and Collaborators
University of New Mexico
Gilead Sciences
Investigators
Principal Investigator: Bina Ahmed, MD Assistant Professor, IM Div Cardiology
  More Information

No publications provided

Responsible Party: Bina Ahmed, Assistant Professor, Internal Medicine Division of Cardiology, University of New Mexico
ClinicalTrials.gov Identifier: NCT01815957     History of Changes
Other Study ID Numbers: 12-069 MICRO Study
Study First Received: March 19, 2013
Last Updated: March 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of New Mexico:
coronary microcirculation
coronary artery disease
myocardial disease
ischemia

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Ischemia
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Ranolazine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014