Randomized clinical trial of aspirin and simvastatin for pulmonary arterial hypertension: ASA-STAT.

ABSTRACT:

Background

Pulmonary arterial hypertension (PAH) is a progressive disease that causes exercise limitation, heart failure, and death. We aimed to determine the safety and efficacy of aspirin and simvastatin in PAH.

Methods and results

We performed a randomized, double-blind, placebo-controlled 2×2 factorial clinical trial of aspirin and simvastatin in patients with PAH receiving background therapy at 4 centers. A total of 92 patients with PAH were to be randomized to aspirin 81 mg or matching placebo and simvastatin 40 mg or matching placebo. The primary outcome was 6-minute walk distance at 6 months. Sixty-five subjects had been randomized when the trial was terminated by the Data Safety and Monitoring Board after an interim analysis showed futility in reaching the primary e

SUBMITTER: Kawut SM 

PROVIDER: S-EPMC3427737 | biostudies-literature | 2011 Jun

REPOSITORIES: biostudies-literature