Phase 4
N=171
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)
Chronic Angina
Bottom Line
View on ClinicalTrials.gov: NCT00644332 ↗Enrolled (actual)
171
Serious AEs
4.7%
Results posted
Jul 2012
Primary outcome: Primary: Evaluate the Validity of the WISQ in Women With Chronic Angina Based on Changes in Patient-reported Angina Frequency and Nitroglycerin (NTG) Consumption Before and Following Treatment With Ranolazine Assessed as Coefficient of Determination (R^2) — 0.337 coefficient of determination
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ranolazine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Gilead Sciences
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluate the Validity of the WISQ in Women With Chronic Angina Based on Changes in Patient-reported Angina Frequency and Nitroglycerin (NTG) Consumption Before and Following Treatment With Ranolazine Assessed as Coefficient of Determination (R^2) |
0.337 | — |
| PRIMARY Evaluate the Reliability of the WISQ in Women With Chronic Angina Based on Changes in Patient-reported Angina Frequency and NTG Consumption Before and Following Treatment With Ranolazine Assessed as Cronbach's Alpha Value |
0.851; 0.308; 0.794 | — |
| PRIMARY Evaluate the Responsiveness of the WISQ in Women With Chronic Angina Based on Changes in Patient-reported Angina Frequency and NTG Consumption Before and Following Treatment With Ranolazine Assessed by Regression Analysis |
0.080 | — |
| SECONDARY Determine Whether the WISQ is Noninferior to the Seattle Angina Questionnaire (SAQ) With Regard to Angina Frequency Items Based on Changes From Baseline (BL) in the Angina Frequency Items of the WISQ With the SAQ Following Ranolazine Treatment |
-0.035 | — |
| SECONDARY Compare Changes From Baseline (BL) in the Physical Limitation Items of the WISQ With the SAQ Following Ranolazine Treatment |
12.2 | — |
| SECONDARY Compare Changes From Baseline (BL) in Other Like Items of the WISQ With the SAQ Following Ranolazine Treatment |
-6.0 | — |
| SECONDARY Determine the Effect of Ranolazine on Angina Frequency as Measured by Patient-reported Diaries |
7.9; 3.2 | — |
| SECONDARY Determine the Effect of Ranolazine on Nitroglycerin Consumption as Measured by Patient-reported Diaries |
4.3; 1.1 | — |
| SECONDARY Determine Changes From Baseline in the Duke Activity Status Index (DASI) Following Ranolazine Treatment |
23.9; 26.8 | — |
| SECONDARY Evaluate the Degree of Correlation Between Changes From Baseline in Items of the WISQ and SAQ With Changes From Baseline in Angina Frequency and NTG Diary Data and the DASI |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT00644332). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.