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)

NCT00644332 | Completed Phase 4 Results

• 1 other identifier: CVT 3041
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 29

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).

Conditions

Chronic Angina

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Secondary Outcomes (7)

• 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

  Baseline to 4 Weeks

• Compare Changes From Baseline (BL) in the Physical Limitation Items of the WISQ With the SAQ Following Ranolazine Treatment

  Baseline to 4 Weeks

• Compare Changes From Baseline (BL) in Other Like Items of the WISQ With the SAQ Following Ranolazine Treatment

  Baseline to 4 Weeks

• Determine the Effect of Ranolazine on Angina Frequency as Measured by Patient-reported Diaries

  Baseline to Week 4

• Determine the Effect of Ranolazine on Nitroglycerin Consumption as Measured by Patient-reported Diaries

  Baseline to Week 4

Interventions

Ranolazine DRUG

Oral dosage form.

Also known as: Ranexa

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (29)

The University of Alabama at Birmingham

Birmingham, Alabama, 35294-0007, United States

Location

Cardiovascular Consultants, Ltd.

Phoenix, Arizona, 85032, United States

Location

Cardiology Consultants of Orange County

Anaheim, California, 92801, United States

Location

Access Clinical Trials/Cardiovascular Research Institute (ACT/CVRI)

Beverly Hills, California, 90210, United States

Location

Escondido Cardiology Associates

Escondido, California, 92025, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Mission Internal Medical Group

Mission Viejo, California, 92691, United States

Location

South Denver Cardiology Associates, PC

Littleton, Colorado, 80120-5654, United States

Location

Guerra Cardiology

Coral Gables, Florida, 33134, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

St. Luke Cardiology Associates

Jacksonville, Florida, 32216, United States

Location

Jacksonville Heart Center, PA

Jacksonville, Florida, 32250, United States

Location

Jacksonville Heart Center, PA

Jacksonville, Florida, 32258, United States

Location

Emory University & Grady Health System

Atlanta, Georgia, 30303, United States

Location

Mercy Physician Group Cardiology

Nampa, Idaho, 83686, United States

Location

North Shore Cardiology

Bannockburn, Illinois, 60015, United States

Location

Gateway Cardiology, P.C.

Jerseyville, Illinois, 62052, United States

Location

Northern Indiana Research Alliance

Fort Wayne, Indiana, 46804, United States

Location

Ashland Hospital Corporation d/b/a King's Daughters Medical Center

Ashland, Kentucky, 41101, United States

Location

University of Louisville, Division of Cardiovascular Medicine

Louisville, Kentucky, 40202, United States

Location

Gateway Cardiology, P.C.

St Louis, Missouri, 63128, United States

Location

Integrated Cardiology Consultants, LLC d.b.a. Bryan LGH Heart Institute

Lincoln, Nebraska, 68506, United States

Location

Albany Associates in Cardiology

Albany, New York, 12205, United States

Location

Total Heart Care, PC

New York, New York, 10128, United States

Location

The Lindner Clinical Trial Center

Cincinnati, Ohio, 45219, United States

Location

St. Vincent Mercy Medical Center, Cardiac Research

Toledo, Ohio, 43608, United States

Location

BlueStem Cardiology

Bartlesville, Oklahoma, 74006, United States

Location

Tri-State Medical Group, Cardiology, Sewickley Valley Medical Group, Cardiology

Beaver, Pennsylvania, 15009, United States

Location

Cardiology Consultants of Philadelphia

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Interventions

Ranolazine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

The study was terminated early at 86% of targeted enrollment (172 of approximately 200 subjects).

Results Point of Contact

• Title: Emmanuelle Bellemin, Senior Manager, Regulatory Affairs
• Organization: Gilead Sciences

emmanuelle.bellemin@gilead.com

Study Officials

• Nanette K. Wenger, MD

  Emory University

  PRINCIPAL INVESTIGATOR

• Noel Bairey Merz, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2008
• First Posted: March 26, 2008
• Study Start: November 1, 2007
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: July 2, 2012
• Results First Posted: July 2, 2012

Record last verified: 2012-05

Locations

US (29)