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)
Condition: Chronic Angina
MeSH terms: Angina Pectoris
Intervention: Ranolazine
Intervention description: Oral dosage form.
Intervention MeSH terms: Ranolazine
Phase: Phase 4
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 172.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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).
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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