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

March 19, 2013
March 19, 2013
May 2012
May 2013   (final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
  • 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.
Same as current
Not Provided
Not Provided
 
Impact of Ranolazine on Coronary Microcirculatory Resistance
Impact of Ranalozine on Coronary Microcirculatory Resistance- A Prospective Single Center Study to Evaluate the Effect of Ranalozine in Microcirculatory Resistance (MICRO Study)

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Coronary Microcirculation
  • Coronary Artery Disease
  • Myocardial Disease
  • Ischemia
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
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.
Intervention: Drug: Rnalozine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
Not Provided
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Bina Ahmed, MD 505-272-2273 BAhmed@Salud.unm.edu
Contact: Lyra Salandre, BA 505-272-9898 LAsalandre@salud.unm.edu
United States
 
NCT01815957
12-069 MICRO Study
No
Bina Ahmed, University of New Mexico
University of New Mexico
Gilead Sciences
Principal Investigator: Bina Ahmed, MD Assistant Professor, IM Div Cardiology
University of New Mexico
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP