QWISE - Study of Quinapril in Women With Chest Pain, Coronary Flow Reserve Limitations and Evidence of Myocardial Ischemia
Status:
Completed
Trial end date:
2004-12-01
Target enrollment:
Participant gender:
Summary
INDICATION Microvascular angina. OBJECTIVES To investigate the effect of ACE (angiotensin
converting enzyme) inhibition (quinapril) in improving coronary microvascular function.
PATIENT POPULATION Women who meet the National Heart, Lung and Blood Institute-sponsored WISE
(Women Ischemia Syndrome Evaluation) study criteria of chest discomfort, coronary flow
reserve limitations and evidence for myocardial ischemia in the absence of significant
coronary artery stenosis.
STUDY DESIGN A prospective, randomized, placebo-controlled, comparative trial. TREATMENT
Quinapril 80 mg/d versus placebo for four months. PRIMARY EFFICACY PARAMETER(S) Coronary flow
reserve (CFR) at Week 16 adjusted for baseline CFR, treatment group assignment, site-specific
variables, and site by treatment effects.
SECONDARY EFFICACY PARAMETERS Week 16 change in chest discomfort as measured by the Seattle
Angina Questionnaire adjusting for baseline values, site, and site by treatment effects.
SAFETY PARAMETERS Hematology, blood chemistries, blood pressure and pulse, and frequency and
occurrence of adverse events.
STATISTICAL RATIONALE AND ANALYSIS A statistical rationale for the number of patients in the
study has been provided. Interim analyses are planned after 15 patients have been enrolled in
each group.
ANTICIPATED TOTAL NUMBER OF PATIENTS 78 (39 per group). ANTICIPATED NUMBER OF PATIENTS AT
EACH SITE Approximately 26