title: Rationale, design, and governance of Prospective Randomized Evaluation of Celecoxib Integrated Safety versus Ibuprofen Or Naproxen (PRECISION), a cardiovascular end point trial of nonsteroidal antiinflammatory agents in patients with arthritis.
abstract: BACKGROUND
  Pain management in patients with osteoarthritis or rheumatoid arthritis often requires long-term use of nonsteroidal antiinflammatory drugs (NSAIDs). However, the relative cardiovascular safety of these therapies remains uncertain.
  
  
  METHODS
  The Prospective Randomized Evaluation of Celecoxib Integrated Safety versus Ibuprofen Or Naproxen (PRECISION) trial will evaluate the cardiovascular safety of celecoxib, ibuprofen, and naproxen. Approximately 20,000 patients with symptomatic osteoarthritis or rheumatoid arthritis at high risk for, or with, established cardiovascular disease will be randomized in this double-blind, triple dummy, multinational, multicenter study. The primary end point is the composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. The trial will continue until 762 primary events occur with at least 18 months follow-up. Noninferiority of any of the regimens will require a 97.5% upper CI of the hazard ratio (HR) < or =1.33 and point estimate < or =1.12 for both intent-to-treat (ITT) and modified ITT populations.
  
  
  CONCLUSIONS
  PRECISION, the first study of patients with high cardiovascular risk chronically treated with a cyclooxygenase-2 selective inhibitor or nonselective NSAID, will define the relative cardiovascular safety profile of celecoxib, ibuprofen, and naproxen and provide data to help guide NSAID use for pain management for this population.
authors.affiliation: Department of Cardiology, Cleveland Clinic Foundation, OH 44195, USA.
authors.forename: Matthew C
authors.initials: MC
authors.lastname: Becker
authors.forename: Thomas H
authors.initials: TH
authors.lastname: Wang
authors.forename: Lisa
authors.initials: L
authors.lastname: Wisniewski
authors.forename: Kathy
authors.initials: K
authors.lastname: Wolski
authors.forename: Peter
authors.initials: P
authors.lastname: Libby
authors.forename: Thomas F
authors.initials: TF
authors.lastname: Lüscher
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Borer
authors.forename: Alice M
authors.initials: AM
authors.lastname: Mascette
authors.forename: M Elaine
authors.initials: ME
authors.lastname: Husni
authors.forename: Daniel H
authors.initials: DH
authors.lastname: Solomon
authors.forename: David Y
authors.initials: DY
authors.lastname: Graham
authors.forename: Neville D
authors.initials: ND
authors.lastname: Yeomans
authors.forename: Henry
authors.initials: H
authors.lastname: Krum
authors.forename: Frank
authors.initials: F
authors.lastname: Ruschitzka
authors.forename: A Michael
authors.initials: AM
authors.lastname: Lincoff
authors.forename: Steven E
authors.initials: SE
authors.lastname: Nissen