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Dual antiplatelet therapy may increase the risk of non-intracranial haemorrhage in patients with minor strokes: a subgroup analysis of the CHANCE trial
  1. David Wang1,
  2. Li Gui2,
  3. Yi Dong3,
  4. Hao Li4,
  5. Shujuan Li5,
  6. Huaguang Zheng6,
  7. Anxin Wang4,6,
  8. Xia Meng4,6,
  9. Li-Ping Liu6,7,
  10. Yi-Long Wang4,6,
  11. Guangyao Wang4,6,
  12. Jing Jing6,7,
  13. Zixiao Li4,6,
  14. Xing-Quan Zhao4,6,
  15. Yong-Jun Wang4,6,8
  16. on behalf of the investigators for the CHANCE trial
  1. 1Illinois Neurological Institute Stroke Network, Sisters of the Third Order of St. Francis Healthcare System, University of Illinois College of Medicine, Peoria, Illinois, USA
  2. 2Southwest Hospital Stroke Center, Third Military University of Medical Sciences, Chongqing, China
  3. 3Department of Neurology, Huashan Hospital, Fudan University, Shanghai, China
  4. 4China National Clinical Research Center for Neurological Diseases, Beijing, China
  5. 5Chaoyang Hospital Neurology Department, Capital Medical University, Beijing, China
  6. 6Department of Neurology, Beijing Tiantan Hospital, Tiantan Clinical Trial and Research Center for Stroke, Capital Medical University, Beijing, China
  7. 7Neurological Intensive Care Unit, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
  8. 8Department of Neurology, Beijing Tiantan Hospital, Vascular Neurology, Capital Medical University, Beijing, China
  1. Correspondence to Professor Yong-Jun Wang; yongjunwang1962{at}gmail.com

Abstract

Aim The aim of this study was to explore the difference between haemorrhagic events among those patients on either aspirin or aspirin plus clopidogrel who were enrolled in the Clopidogrel in High-Risk Patients with Acute Non-disabling Ischemic Cerebrovascular Events (CHANCE) trial.

Methods This was an ad hoc analysis of the CHANCE trial; data on all patients with any haemorrhagic event were reviewed and analysed. Cox proportional hazards regression was used to determine factors association with any bleeding.

Results In the CHANCE trial, there were a total of 101 (2%) haemorrhagic events reported from 50 different hospitals. The clopidogrel–aspirin group had 60 (2.3%) cases and the aspirin group had 41 (1.6%, p=0.09). Moderate or severe haemorrhagic events occurred in 7 patients (0.3%) in the clopidogrel–aspirin group and in 8 (0.3%) in the aspirin group (p=0.73). Of 36 (0.7%) cases of intracranial haemorrhages, 20 (0.4%) were in the clopidogrel–aspirin group and 16 (0.3%) in the aspirin group. Each group had 8 (0.3%) cases of symptomatic haemorrhagic strokes. Other common haemorrhagic events included 24 (0.5%) cases of skin bruises, 13 (0.3%) gastrointestinal haemorrhages, 9 (0.2%) gum haemorrhages and 8 (0.2%) intraocular haemorrhages.

Conclusions There was no overall significant difference in haemorrhagic events (p=0.29), especially in the rate of intracranial haemorrhages between the 2 treatment groups. However, patients enrolled with minor strokes had an increased risk of haemorrhagic events regardless of treatment group, not seen in patients with high-risk transient ischaemic attacks. Being elderly, of male gender and with a history of aspirin or proton pump inhibitor usage were associated with increased risk of haemorrhage. Patients with higher body mass index had lower risk of haemorrhagic events.

Trial registration number NCT00979589.

  • Hemorrhage
  • dual antiplatelet
  • minor stroke
  • TIA
  • stroke prevention

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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