Clopidogrel plus aspirin versus warfarin in patients with stroke and aortic arch plaques

Aortic Arch Related Cerebral Hazard Trial Investigators, Pierre Amarenco, Stephen Davis, Elizabeth F Jones, Ariel A Cohen, Wolf-Dieter Heiss, Markku Kaste, Cédric Laouénan, Dennis Young, Malcolm Macleod, Geoffrey A Donnan

Research output: Contribution to journalArticlepeer-review

Abstract / Description of output

BACKGROUND AND PURPOSE: Severe atherosclerosis in the aortic arch is associated with a high risk of recurrent vascular events, but the optimal antithrombotic strategy is unclear.

METHODS: This prospective randomized controlled, open-labeled trial, with blinded end point evaluation (PROBE design) tested superiority of aspirin 75 to 150 mg/d plus clopidogrel 75 mg/d (A+C) over warfarin therapy (international normalized ratio 2-3) in patients with ischemic stroke, transient ischemic attack, or peripheral embolism with plaque in the thoracic aorta>4 mm and no other identified embolic source. The primary end point included cerebral infarction, myocardial infarction, peripheral embolism, vascular death, or intracranial hemorrhage. Follow-up visits occurred at 1 month and then every 4 months post randomization.

RESULTS: The trial was stopped after 349 patients were randomized during a period of 8 years and 3 months. After a median follow-up of 3.4 years, the primary end point occurred in 7.6% (13/172) and 11.3% (20/177) of patients on A+C and on warfarin, respectively (log-rank, P=0.2). The adjusted hazard ratio was 0.76 (95% confidence interval, 0.36-1.61; P=0.5). Major hemorrhages including intracranial hemorrhages occurred in 4 and 6 patients in the A+C and warfarin groups, respectively. Vascular deaths occurred in 0 patients in A+C arm compared with 6 (3.4%) patients in the warfarin arm (log-rank, P=0.013). Time in therapeutic range (67% of the time for international normalized ratio 2-3) analysis by tertiles showed no significant differences across groups.

CONCLUSIONS: Because of lack of power, this trial was inconclusive and results should be taken as hypothesis generating.

CLINICAL TRIAL REGISTRATION URL: Unique identifier: NCT00235248.

Original languageEnglish
Pages (from-to)1248-57
Number of pages10
JournalStroke; a journal of cerebral circulation
Issue number5
Publication statusPublished - May 2014

Keywords / Materials (for Non-textual outputs)

  • Aged
  • Aged, 80 and over
  • Anticoagulants
  • Aorta, Thoracic
  • Aortic Diseases
  • Aspirin
  • Brain Ischemia
  • Drug Therapy, Combination
  • Embolism
  • Female
  • Humans
  • Male
  • Middle Aged
  • Plaque, Atherosclerotic
  • Platelet Aggregation Inhibitors
  • Prospective Studies
  • Single-Blind Method
  • Stroke
  • Ticlopidine
  • Treatment Outcome
  • Warfarin


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