Chronic Angina Clinical Trial
Official title:
An Open-label, Multi-center Study Evaluating the Validity, Reliability, and Responsiveness of a New Women's Ischemia Symptom Questionnaire in Women With Chronic Angina Treated With Ranolazine Extended-release Tablets (CVT 3041)
| Verified date | May 2012 |
| Source | Gilead Sciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 172 |
| Est. completion date | January 2011 |
| Est. primary completion date | January 2011 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| United States | Albany Associates in Cardiology | Albany | New York |
| United States | Cardiology Consultants of Orange County | Anaheim | California |
| United States | Ashland Hospital Corporation d/b/a King's Daughters Medical Center | Ashland | Kentucky |
| United States | Emory University & Grady Health System | Atlanta | Georgia |
| United States | North Shore Cardiology | Bannockburn | Illinois |
| United States | BlueStem Cardiology | Bartlesville | Oklahoma |
| United States | Tri-State Medical Group, Cardiology, Sewickley Valley Medical Group, Cardiology | Beaver | Pennsylvania |
| United States | Access Clinical Trials/Cardiovascular Research Institute (ACT/CVRI) | Beverly Hills | California |
| United States | The University of Alabama at Birmingham | Birmingham | Alabama |
| United States | The Lindner Clinical Trial Center | Cincinnati | Ohio |
| United States | Guerra Cardiology | Coral Gables | Florida |
| United States | Escondido Cardiology Associates | Escondido | California |
| United States | Northern Indiana Research Alliance | Fort Wayne | Indiana |
| United States | Jacksonville Center for Clinical Research | Jacksonville | Florida |
| United States | Jacksonville Heart Center, PA | Jacksonville | Florida |
| United States | Jacksonville Heart Center, PA | Jacksonville | Florida |
| United States | St. Luke Cardiology Associates | Jacksonville | Florida |
| United States | Gateway Cardiology, P.C. | Jerseyville | Illinois |
| United States | Integrated Cardiology Consultants, LLC d.b.a. Bryan LGH Heart Institute | Lincoln | Nebraska |
| United States | South Denver Cardiology Associates, PC | Littleton | Colorado |
| United States | Cedars-Sinai Medical Center | Los Angeles | California |
| United States | University of Louisville, Division of Cardiovascular Medicine | Louisville | Kentucky |
| United States | Mission Internal Medical Group | Mission Viejo | California |
| United States | Mercy Physician Group Cardiology | Nampa | Idaho |
| United States | Total Heart Care, PC | New York | New York |
| United States | Cardiology Consultants of Philadelphia | Philadelphia | Pennsylvania |
| United States | Cardiovascular Consultants, Ltd. | Phoenix | Arizona |
| United States | Gateway Cardiology, P.C. | St. Louis | Missouri |
| United States | St. Vincent Mercy Medical Center, Cardiac Research | Toledo | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Gilead Sciences |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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) | Validity of the WISQ was assessed by regression analysis. Results of this analysis are reported as the estimated coefficient of determination (R^2) of the WISQ Total Score at 4 weeks regressed on 4-week angina frequency, 4-week NTG use, and DASI score at 4 weeks. For mean (SEM) Baseline and Week 4 values for angina frequency and NTG use, please refer to Secondary Outcome Measures 7 and 8. For mean (SEM) Baseline and Week 4 DASI values, please refer to Secondary Outcome Measure 9. | Baseline to Week 4 | No |
| 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 | Reliability of the WISQ was assessed by estimating Cronbach's alpha (standardized); values of 0.7 or higher were to be considered adequate. (Standardized Cronbach's alpha is a coefficient of reliability or consistency, and is a function of the average inter-item correlation.) Cronbach's alpha was calculated for the WISQ instrument overall and for the Angina Frequency/Severity and Angina Stability subscales. Missing item responses were not imputed. | Baseline to Week 4 | No |
| 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 | Responsiveness of the WISQ was assessed as the estimated coefficient of determination (R^2) of the change from baseline WISQ Total Score at 4 weeks regressed on change from baseline angina frequency and change from baseline NTG use. For mean (SEM) Baseline and Week 4 values for angina frequency and NTG use, please refer to Secondary Outcome Measures 7 and 8. | Baseline to Week 4 | No |
| 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 | Changes from BL in angina frequency items following ranolazine treatment were measured. Analysis: multiple linear regression; response variable: ?WISQ - ?SAQ; independent variables: age and BL WISQ and SAQ scores. WISQ items: 15 points (higher=more severe state); SAQ items: 12 points (lower=more severe state). WISQ scores were recalibrated by multiplying by .75. Noninferiority was to be considered demonstrated if the lower limit of a 2-sided 95% CI for WISQ mean - SAQ mean was above the prespecified margin (WISQ vs SAQ difference of -2). | Baseline to 4 Weeks | No |
| Secondary | Compare Changes From Baseline (BL) in the Physical Limitation Items of the WISQ With the SAQ Following Ranolazine Treatment | Changes from BL in stress, excitement, temperature, satiety, anger, and other limitation items following ranolazine treatment were measured. Analysis: multiple linear regression; response variable: ?WISQ - ?SAQ; independent variables: age and BL WISQ and SAQ scores. WISQ items: 27 points (higher=more severe state); SAQ items: 45 points (lower=more severe state). WISQ scores were recalibrated by multiplying by 15/27. Noninferiority was to be considered demonstrated if the lower limit of a 2-sided 95% CI for WISQ mean - SAQ mean was above the prespecified margin (WISQ vs SAQ difference of -2). | Baseline to 4 Weeks | No |
| Secondary | Compare Changes From Baseline (BL) in Other Like Items of the WISQ With the SAQ Following Ranolazine Treatment | Changes from BL in stress, excitement, temperature, satiety, anger, and other limitation items following ranolazine treatment were measured. Analysis: multiple linear regression; response variable: ?WISQ - ?SAQ; independent variables: age and BL WISQ and SAQ scores. WISQ items: 27 points (higher=more severe state); SAQ items: 45 points (lower=more severe state). WISQ scores were recalibrated by multiplying by 15/27. Noninferiority was to be considered demonstrated if the lower limit of a 2-sided 95% CI for WISQ mean - SAQ mean was above the prespecified margin (WISQ vs SAQ difference of -2). | Baseline to 4 Weeks | No |
| Secondary | Determine the Effect of Ranolazine on Angina Frequency as Measured by Patient-reported Diaries | Angina episodes were recorded by subjects in their diaries. Weekly frequency of angina episodes was calculated for the two-week baseline period and the last two weeks of the study. | Baseline to Week 4 | No |
| Secondary | Determine the Effect of Ranolazine on Nitroglycerin Consumption as Measured by Patient-reported Diaries | Nitroglycerin use was recorded by subjects in their diaries. Weekly frequency of NTG use was calculated for the two-week baseline period and the last two weeks of the study. | Baseline to Week 4 | No |
| Secondary | Determine Changes From Baseline in the Duke Activity Status Index (DASI) Following Ranolazine Treatment | The DASI was analyzed as mean values at baseline and Week 4. The DASI is a self-administered questionnaire that measures a patient's functional capacity. It can be used to get a rough estimate of a patient's peak oxygen uptake. The maximum score for the DASI is 58.2 (better functional ability/capacity) and the minimum score is 0 (worse functional ability/capacity). | Baseline to Week 4 | No |
| 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 | The DASI is a self-administered questionnaire that measures a patient's functional capacity. It can be used to get a rough estimate of a patient's peak oxygen uptake. The maximum score for the DASI is 58.2 (better functional ability/capacity) and the minimum score is 0 (worse functional ability/capacity). The planned analysis was the amount of variation in WISQ and SAQ score changes from baseline explained by changes in angina frequency, NTG use, and DASI score assessed by multiple linear regression analysis. | Baseline to Week 4 | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
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