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)

Completed · Phase 4

Conditions studied: Chronic Angina

In brief

According to the American Heart Association (AHA) 2011 update of heart disease and stroke statistics, more than 9 million adult patients in the United States (US) have angina. This update also notes that a study of 4 national cross-sectional health examination studies found that, among Americans 40 to 74 years of age, the age-adjusted prevalence of angina was higher among women than men. 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. However, evaluating angina and responses to antianginal therapy is often not straightforward. This is particularly true of female patients with angina. 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 the newly developed Women's Ischemia Symptom Questionnaire (WISQ) based on changes in angina symptomatology in a female angina population treated with ranolazine, compared with the widely used Seattle Angina Questionnaire (SAQ).

Key facts

Study ID

NCT00644332

Run by

Gilead Sciences

People needed

172

Starts

2007-11-01

Expected to finish

2011-01-01

Last updated by the study team

2012-07-02

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• At least 3 months of documented history of stable angina or angina equivalents that is relieved by rest and/or sublingual NTG
• Taking antianginal therapy with beta-blockers, and/or dihydropyridine calcium antagonists, and/or long-acting nitrates for at least 4 weeks
• Mean angina frequency of ≥ 2 attacks per week
• Documented clinical evidence of ischemia

You may not qualify if…

• Clinically significant hepatic impairment
• Uncontrolled clinically significant cardiac arrhythmias or a history of ventricular fibrillation, torsades de points, or other life-threatening ventricular arrhythmias not associated with acute coronary syndrome
• Treatment with strong cytochrome P450 inhibitors including ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, or saquinavir
• Prior treatment with ranolazine
• End-stage renal disease requiring dialysis
• Myocardial infarction or unstable angina

Where it is running

• The University of Alabama at Birmingham — Birmingham, Alabama, United States
• Cardiovascular Consultants, Ltd. — Phoenix, Arizona, United States
• Cardiology Consultants of Orange County — Anaheim, California, United States
• Access Clinical Trials/Cardiovascular Research Institute (ACT/CVRI) — Beverly Hills, California, United States
• Escondido Cardiology Associates — Escondido, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Mission Internal Medical Group — Mission Viejo, California, United States
• South Denver Cardiology Associates, PC — Littleton, Colorado, United States
• Guerra Cardiology — Coral Gables, Florida, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• St. Luke Cardiology Associates — Jacksonville, Florida, United States
• Jacksonville Heart Center, PA — Jacksonville, Florida, United States
• Jacksonville Heart Center, PA — Jacksonville, Florida, United States
• Emory University & Grady Health System — Atlanta, Georgia, United States
• Mercy Physician Group Cardiology — Nampa, Idaho, United States
• North Shore Cardiology — Bannockburn, Illinois, United States
• Gateway Cardiology, P.C. — Jerseyville, Illinois, United States
• Northern Indiana Research Alliance — Fort Wayne, Indiana, United States
• Ashland Hospital Corporation d/b/a King's Daughters Medical Center — Ashland, Kentucky, United States
• University of Louisville, Division of Cardiovascular Medicine — Louisville, Kentucky, United States
• Gateway Cardiology, P.C. — St Louis, Missouri, United States
• Integrated Cardiology Consultants, LLC d.b.a. Bryan LGH Heart Institute — Lincoln, Nebraska, United States
• Albany Associates in Cardiology — Albany, New York, United States
• Total Heart Care, PC — New York, New York, United States
• The Lindner Clinical Trial Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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