title: Study design and rationale for the Stabilization of pLaques usIng Darapladib-Thrombolysis in Myocardial Infarction (SOLID-TIMI 52) trial in patients after an acute coronary syndrome.
abstract: BACKGROUND
  Higher levels of lipoprotein-associated phospholipase A(2) (Lp-PLA(2)) are associated with a higher risk of cardiovascular events and may play a causal role in atherogenesis. Darapladib inhibits Lp-PLA(2) activity in plasma and in arterial plaques and may confer clinical benefit in preventing cardiovascular events.
  
  
  METHODS
  The SOLID-TIMI 52 trial is a randomized, double-blind, placebo-controlled, multicenter, event-driven trial. Approximately 13,000 subjects are being randomized to darapladib (160 mg enteric-coated tablet daily) or matching placebo within 30 days of hospitalization with an acute coronary syndrome. The primary end point is the composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. Secondary end points include major and total coronary events, individual components of the primary end point, and all-cause mortality. The study will continue until approximately 1,500 primary end point events have occurred to achieve 90% power to detect a 15.5% reduction in the primary end point. The median treatment duration is anticipated to be approximately 3 years, with a total study duration of approximately 4.1 years.
  
  
  CONCLUSIONS
  The SOLID-TIMI 52 trial will determine the clinical benefit of direct inhibition of Lp-PLA(2) activity with darapladib in patients after an acute coronary syndrome.
authors: TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA.
authors: Michelle L
authors: ML
authors: O'Donoghue
authors: Eugene
authors: E
authors: Braunwald
authors: Harvey D
authors: HD
authors: White
authors: Patrick
authors: P
authors: Serruys
authors: Ph Gabriel
authors: PG
authors: Steg
authors: Judith
authors: J
authors: Hochman
authors: Aldo P
authors: AP
authors: Maggioni
authors: Christoph
authors: C
authors: Bode
authors: Douglas
authors: D
authors: Weaver
authors: Joel L
authors: JL
authors: Johnson
authors: Greg
authors: G
authors: Cicconetti
authors: Mary Ann
authors: MA
authors: Lukas
authors: Elizabeth
authors: E
authors: Tarka
authors: Christopher P
authors: CP
authors: Cannon
mesh_terms: D054058:Acute Coronary Syndrome / Q000188:drug therapy*; D001547:Benzaldehydes / Q000627:therapeutic use*; D004311:Double-Blind Method; D006801:Humans; D009203:Myocardial Infarction / Q000517:prevention & control*; D010091:Oximes / Q000627:therapeutic use*; D012107:Research Design; D015912:Thrombolytic Therapy; D001713:Biphenyl Compounds; D004048:Diethylamines; D011744:Pyrimidinones; D013440:Sulfides
chemical_list: D001547:Benzaldehydes; D010091:Oximes; C529040:darapladib; D001713:Biphenyl Compounds; D004048:Diethylamines; D011744:Pyrimidinones; D013440:Sulfides