Recruiting

Ranolazine

Sponsor:

Westside Medical Associates of Los Angeles

Code:

NCT01804543

Conditions

Angina

Heart Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ranolazine

Study Details

Brief summary:

Evaluation of use of ranolazine in patients with stable heart pain with cardiac magnetic resonance imaging (CMRI) and phosphorous-31 magnetic resonance spectroscopy (31P MRS). Subsequent testing using these modalities will show improved oxygen to the heart muscle.

Conditions

Angina

Heart Disease

Study ID

NCT01804543

Start date

Jun, 2012

Status verified date

Mar, 2013

Completion date

Dec, 2014

Anticipated

Primary completion date

Dec, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age >18 years of age with stable angina pectoris or an anginal equivalent symptom (e.g. atypical chest discomfort, dyspnea, easy fatigue) AND
2. Mild, moderate or severe myocardial ischemia detected on nuclear perfusion imaging (exercise or pharmacologic SPECT or Rubidium PET), exercise stress echocardiography or stress cardiac MRI OR Documentation of obstructive coronary artery with at least one major coronary artery (left anterior descending, circumflex or right coronary artery) of at least 70% by either conventional or CT coronary angiography.

Exclusion Criteria:

1. Acute coronary syndrome including unstable angina or non ST elevation myocardial infarction within the last 60 days
2. ST-elevation myocardial infarction within 60 days
3. Equivocal myocardial ischemia on non-invasive testing or studies demonstrating reversible perfusion defects complicated by significant attenuation artifacts.
4. Recent PCI within the last 60 days
5. Recent CABG within the last 60 days
6. Inability to sign informed consent
7. Patients who have taken ranolazine within 30 days of screening
8. Patients taking strong CYP3A inhibitors e.g. ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir
9. Patients taking inducers of CYP3A e.g. rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, and St. John's wort
10. Patients with liver cirrhosis or liver disease that is Grade B or C by the Child-Pugh Classification
11. Prior allergic reaction or intolerance to ranolazine
12. Patients with a history of inherited or acquired prolonged QT interval
13. Moderate to severe claustrophobia or previous inability to undergo an MRI exam
14. Patients with implanted pacemaker or internal cardiac defibrillator
15. Patients who have a metallic foreign body implants (metal silver in their eye, cochlear implants) or have an aneurysm clip in their brain
16. GFR < 30 ml/m2
17. Type 2 second degree heart block (Mobitz II) in the absence of functioning permanent pacemaker.
18. Sinus node dysfunction in the absence of functioning permanent pacemaker.
19. Patients taking dipyridamole therapy.
20. Active bronchospasm (active asthma or COPD with active wheezing.

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Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Angina, Heart Disease

ranolazine 500 mg twice daily for 1 week, then 1000 mg twice daily for 3 weeks

Interventions

Ranolazine

ranolazine 500 mg, then 1000 mg twice a day

Primary outcome measure

  • parameters of cellular ischemia by 31P MRS [ Time Frame: post 4 weeks of therapy with ranolazine ]

Central Contacts and Locations

Central contacts

Locations

Westside Medical Associates of Los Angeles

Recruiting

Beverly Hills, California, United States, 90211

Contacts

Principal Investigator:

Gabriel Vorobiof, MD

More Information

Sponsor

Westside Medical Associates of Los Angeles

Last update posted

Mar 5, 2013

Last verified

Mar, 2013

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Westside Medical Associates of Los Angeles on 2013-03-05.