Clinical trial NCT00644332: 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)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Angina
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2008-03-26
Enrollment: 172
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief 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

Primary outcomes:
measure: 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)
timeFrame: Baseline to Week 4
measure: 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
timeFrame: Baseline to Week 4
measure: 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
timeFrame: Baseline to Week 4
Secondary outcomes:
measure: 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
timeFrame: Baseline to 4 Weeks
measure: Compare Changes From Baseline (BL) in the Physical Limitation Items of the WISQ With the SAQ Following Ranolazine Treatment
timeFrame: Baseline to 4 Weeks
measure: Compare Changes From Baseline (BL) in Other Like Items of the WISQ With the SAQ Following Ranolazine Treatment
timeFrame: Baseline to 4 Weeks
measure: Determine the Effect of Ranolazine on Angina Frequency as Measured by Patient-reported Diaries
timeFrame: Baseline to Week 4
measure: Determine the Effect of Ranolazine on Nitroglycerin Consumption as Measured by Patient-reported Diaries
timeFrame: Baseline to Week 4
measure: Determine Changes From Baseline in the Duke Activity Status Index (DASI) Following Ranolazine Treatment
timeFrame: Baseline to Week 4
measure: 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
timeFrame: Baseline to Week 4
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Cardiovascular Consultants, Ltd.
state: Arizona
city: Anaheim
country: United States
facility: Cardiology Consultants of Orange County
state: California
city: Beverly Hills
country: United States
facility: Access Clinical Trials/Cardiovascular Research Institute (ACT/CVRI)
state: California
city: Escondido
country: United States
facility: Escondido Cardiology Associates
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Mission Viejo
country: United States
facility: Mission Internal Medical Group
state: California
city: Littleton
country: United States
facility: South Denver Cardiology Associates, PC
state: Colorado
city: Coral Gables
country: United States
facility: Guerra Cardiology
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: St. Luke Cardiology Associates
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Heart Center, PA
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Heart Center, PA
state: Florida
city: Atlanta
country: United States
facility: Emory University & Grady Health System
state: Georgia
city: Nampa
country: United States
facility: Mercy Physician Group Cardiology
state: Idaho
city: Bannockburn
country: United States
facility: North Shore Cardiology
state: Illinois
city: Jerseyville
country: United States
facility: Gateway Cardiology, P.C.
state: Illinois
city: Fort Wayne
country: United States
facility: Northern Indiana Research Alliance
state: Indiana
city: Ashland
country: United States
facility: Ashland Hospital Corporation d/b/a King's Daughters Medical Center
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville, Division of Cardiovascular Medicine
state: Kentucky
city: St. Louis
country: United States
facility: Gateway Cardiology, P.C.
state: Missouri
city: Lincoln
country: United States
facility: Integrated Cardiology Consultants, LLC d.b.a. Bryan LGH Heart Institute
state: Nebraska
city: Albany
country: United States
facility: Albany Associates in Cardiology
state: New York
city: New York
country: United States
facility: Total Heart Care, PC
state: New York
city: Cincinnati
country: United States
facility: The Lindner Clinical Trial Center
state: Ohio
city: Toledo
country: United States
facility: St. Vincent Mercy Medical Center, Cardiac Research
state: Ohio
city: Bartlesville
country: United States
facility: BlueStem Cardiology
state: Oklahoma
city: Beaver
country: United States
facility: Tri-State Medical Group, Cardiology, Sewickley Valley Medical Group, Cardiology
state: Pennsylvania
city: Philadelphia
country: United States
facility: Cardiology Consultants of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Emory University
name: Nanette K. Wenger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cedars-Sinai Medical Center
name: Noel Bairey Merz, MD
role: PRINCIPAL_INVESTIGATOR
References: