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Clinical
Research Study
Mercy St. Vincent Medical Center
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An Open-Label, Multi-Center Study Evaluating the Validity,
Reliability, and Responsiveness of a New Female-Specific Angina
Questionnaire in Women With Chronic Angina
Treated With Ranolazine Extended-Release Tablets (CVT 3041)
Sponsored by: CV Therapeutics, October 2008
Purpose
Of the estimated 8.9 million angina patients in the United States,
over half are women (4.6 million). Per ACC/AHA guidelines, the goal of antianginal
therapy is the complete or near complete elimination of anginal chest pain and
a return to normal activities and functional capacity. Evaluating angina and
responses to antianginal therapy however is often not straightforward. This
is particularly true of the female angina patient. Because angina and response
to antianginal therapy may differ in men and women, an instrument designed specifically
to address symptomatology in women with angina could enhance our understanding
and characterization of angina and responses to therapy in this population.
The current study will evaluate the validity, reliability, and responsiveness
of a newly developed Female-specific Angina Questionnaire (FAQ) based on changes
in angina symptomatology in a female angina population treated with ranolazine.
Eligibility
| Ages Eligible for Study: |
18 Years and older |
| Genders Eligible for Study: |
Female |
| Accepts Healthy Volunteers: |
No |
Criteria
Inclusion Criteria:
Documented history of stable angina or angina equivalents that is relieved
by rest and/or sublingual nitroglycerin
Taking antianginal therapy with beta-blockers, and/or dihydropyridine calcium
antagonists, and/or long-acting nitrates
Mean angina frequency of ? 2 attacks per week
Documented clinical evidence of ischemia
Exclusion Criteria:
QTc > 500 ms on resting ECG
Hepatic impairment (Child-Pugh Classes A [mild], B [moderate] or C [severe])
Treatment with QT prolonging drugs such as Class IA (e.g. quinidine) and Class
III (e.g. sotalol, dofetilide) antiarrhythmics, amiodarone, and antipsychotics
(e.g. thioridazine, ziprasidone)
Treatment with potent or moderately potent CYP 3A inhibitors including ketoconazole
and other azole antifungals, diltiazem, verapamil, macrolide antibiotics, HIV
protease inhibitors or consumption of grapefruit juice or grapefruit containing
products
Prior treatment with ranolazine
Contacts
Physicians:
Ameer Kabour, MD
Mohammad Alkhateeb, MD
Raza Hashmi, MD
Tarif Kanaan, MD
Coordinators:
Michelle Hickam, BSN
Julie Neidhardt, BSN
Brenda Hoagland, RN, CCRC
Please contact us at 419-251-4919 for more information about this study.
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