title: Prasugrel versus clopidogrel for acute coronary syndromes without revascularization.
abstract: BACKGROUND
  The effect of intensified platelet inhibition for patients with unstable angina or myocardial infarction without ST-segment elevation who do not undergo revascularization has not been delineated.
  
  
  METHODS
  In this double-blind, randomized trial, in a primary analysis involving 7243 patients under the age of 75 years receiving aspirin, we evaluated up to 30 months of treatment with prasugrel (10 mg daily) versus clopidogrel (75 mg daily). In a secondary analysis involving 2083 patients 75 years of age or older, we evaluated 5 mg of prasugrel versus 75 mg of clopidogrel.
  
  
  RESULTS
  At a median follow-up of 17 months, the primary end point of death from cardiovascular causes, myocardial infarction, or stroke among patients under the age of 75 years occurred in 13.9% of the prasugrel group and 16.0% of the clopidogrel group (hazard ratio in the prasugrel group, 0.91; 95% confidence interval [CI], 0.79 to 1.05; P=0.21). Similar results were observed in the overall population. The prespecified analysis of multiple recurrent ischemic events (all components of the primary end point) suggested a lower risk for prasugrel among patients under the age of 75 years (hazard ratio, 0.85; 95% CI, 0.72 to 1.00; P=0.04). Rates of severe and intracranial bleeding were similar in the two groups in all age groups. There was no significant between-group difference in the frequency of nonhemorrhagic serious adverse events, except for a higher frequency of heart failure in the clopidogrel group.
  
  
  CONCLUSIONS
  Among patients with unstable angina or myocardial infarction without ST-segment elevation, prasugrel did not significantly reduce the frequency of the primary end point, as compared with clopidogrel, and similar risks of bleeding were observed. (Funded by Eli Lilly and Daiichi Sankyo; TRILOGY ACS ClinicalTrials.gov number, NCT00699998.).
authors.affiliation: Duke Clinical Research Institute and Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC 27705, USA. matthew.roe@duke.edu
authors.forename: Matthew T
authors.initials: MT
authors.lastname: Roe
authors.forename: Paul W
authors.initials: PW
authors.lastname: Armstrong
authors.forename: Keith A A
authors.initials: KA
authors.lastname: Fox
authors.forename: Harvey D
authors.initials: HD
authors.lastname: White
authors.forename: Dorairaj
authors.initials: D
authors.lastname: Prabhakaran
authors.forename: Shaun G
authors.initials: SG
authors.lastname: Goodman
authors.forename: Jan H
authors.initials: JH
authors.lastname: Cornel
authors.forename: Deepak L
authors.initials: DL
authors.lastname: Bhatt
authors.forename: Peter
authors.initials: P
authors.lastname: Clemmensen
authors.forename: Felipe
authors.initials: F
authors.lastname: Martinez
authors.forename: Diego
authors.initials: D
authors.lastname: Ardissino
authors.forename: Jose C
authors.initials: JC
authors.lastname: Nicolau
authors.forename: William E
authors.initials: WE
authors.lastname: Boden
authors.forename: Paul A
authors.initials: PA
authors.lastname: Gurbel
authors.forename: Witold
authors.initials: W
authors.lastname: Ruzyllo
authors.forename: Anthony J
authors.initials: AJ
authors.lastname: Dalby
authors.forename: Darren K
authors.initials: DK
authors.lastname: McGuire
authors.forename: Jose L
authors.initials: JL
authors.lastname: Leiva-Pons
authors.forename: Alexander
authors.initials: A
authors.lastname: Parkhomenko
authors.forename: Shmuel
authors.initials: S
authors.lastname: Gottlieb
authors.forename: Gracita O
authors.initials: GO
authors.lastname: Topacio
authors.forename: Christian
authors.initials: C
authors.lastname: Hamm
authors.forename: Gregory
authors.initials: G
authors.lastname: Pavlides
authors.forename: Assen R
authors.initials: AR
authors.lastname: Goudev
authors.forename: Ali
authors.initials: A
authors.lastname: Oto
authors.forename: Chuen-Den
authors.initials: CD
authors.lastname: Tseng
authors.forename: Bela
authors.initials: B
authors.lastname: Merkely
authors.forename: Vladimir
authors.initials: V
authors.lastname: Gasparovic
authors.forename: Ramon
authors.initials: R
authors.lastname: Corbalan
authors.forename: Mircea
authors.initials: M
authors.lastname: Cinteză
authors.forename: R Craig
authors.initials: RC
authors.lastname: McLendon
authors.forename: Kenneth J
authors.initials: KJ
authors.lastname: Winters
authors.forename: Eileen B
authors.initials: EB
authors.lastname: Brown
authors.forename: Yuliya
authors.initials: Y
authors.lastname: Lokhnygina
authors.forename: Philip E
authors.initials: PE
authors.lastname: Aylward
authors.forename: Kurt
authors.initials: K
authors.lastname: Huber
authors.forename: Judith S
authors.initials: JS
authors.lastname: Hochman
authors.forename: E Magnus
authors.initials: EM
authors.lastname: Ohman
mesh_terms: D054058:Acute Coronary Syndrome / Q000188:drug therapy*; D000368:Aged; D000789:Angina, Unstable / Q000188:drug therapy*; D001241:Aspirin / Q000627:therapeutic use; D002318:Cardiovascular Diseases / Q000401:mortality / Q000517:prevention & control; D000077144:Clopidogrel; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy* / Q000453:epidemiology; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D000068799:Prasugrel Hydrochloride; D058919:Purinergic P2 Receptor Antagonists / Q000009:adverse effects / Q000627:therapeutic use; D020521:Stroke / Q000453:epidemiology; D013876:Thiophenes / Q000009:adverse effects / Q000627:therapeutic use*; D013988:Ticlopidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D010879:Piperazines; D010975:Platelet Aggregation Inhibitors; D058919:Purinergic P2 Receptor Antagonists; D013876:Thiophenes; D000077144:Clopidogrel; D000068799:Prasugrel Hydrochloride; D013988:Ticlopidine; D001241:Aspirin