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Rationale and design of a phase II clinical trial of aspirin and simvastatin for the treatment of pulmonary arterial hypertension: ASA-STAT

Steven M. Kawut; Emilia Bagiella; Daichi Shimbo; David J. Lederer; Nadine Al-Naamani; Kari E. Roberts; R. Graham Barr; Wendy Post; Evelyn Horn; Russell P. Tracy; Paul M. Hassoun; Reda Girgis; ASA-STAT Study Group

Title:
Rationale and design of a phase II clinical trial of aspirin and simvastatin for the treatment of pulmonary arterial hypertension: ASA-STAT
Author(s):
Kawut, Steven M.
Bagiella, Emilia
Shimbo, Daichi
Lederer, David J.
Al-Naamani, Nadine
Roberts, Kari E.
Barr, R. Graham
Post, Wendy
Horn, Evelyn
Tracy, Russell P.
Hassoun, Paul M.
Girgis, Reda
ASA-STAT Study Group
Date:
Type:
Articles
Department(s):
Medicine
Center for Behavioral Cardiovascular Health
Biostatistics
Volume:
32
Persistent URL:
Book/Journal Title:
Contemporary Clinical Trials
Publisher:
Elsevier
Abstract:
Background - Pulmonary arterial hypertension (PAH) is a progressive disease which causes exercise limitation, heart failure, and death. Aspirin and simvastatin are highly effective and safe therapies for other cardiovascular diseases characterized by platelet activation and endothelial dysfunction, but have not been formally studied in PAH. Methods - ASA-STAT is a phase II, randomized, double-blind, placebo-controlled 2 × 2 factorial clinical trial of aspirin and simvastatin in patients with PAH. A total of 92 subjects were to be randomized to aspirin or aspirin placebo and simvastatin or simvastatin placebo. The primary outcome is the distance walked in 6 min at 6 months after randomization. Secondary measures include brachial artery flow-mediated dilation, circulating biomarkers of platelet and endothelial function, functional class, quality-of-life, and time to clinical end points. The incidence of adverse events will be compared between treatment groups. Screening and enrollment - We screened a total of 712 individuals with PAH. Sixty-five subjects were enrolled when the trial was terminated for futility in reaching the primary end point for simvastatin. Conclusions - This study aims to determine whether aspirin or simvastatin have beneficial biologic or clinical effects in patients with PAH. The safety and side effects of these commonly prescribed cardiovascular drugs will also be assessed.
Subject(s):
Aspirin--Therapeutic use
Pulmonary hypertension
Blood platelets
Statins (Cardiovascular agents)
Medical sciences
Epidemiology
Medicine
Publisher DOI:
https://doi.org/10.1016/j.cct.2010.12.005
Item views
233
Metadata:
text | xml
Suggested Citation:
Steven M. Kawut, Emilia Bagiella, Daichi Shimbo, David J. Lederer, Nadine Al-Naamani, Kari E. Roberts, R. Graham Barr, Wendy Post, Evelyn Horn, Russell P. Tracy, Paul M. Hassoun, Reda Girgis, ASA-STAT Study Group, , Rationale and design of a phase II clinical trial of aspirin and simvastatin for the treatment of pulmonary arterial hypertension: ASA-STAT, Columbia University Academic Commons, .

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