Ticagrelor in Acute Stroke or Transient Ischemic Attack in Asian Patients: From the SOCRATES Trial (Acute Stroke or Transient Ischemic Attack Treated With Aspirin or Ticagrelor and Patient Outcomes)

Stroke. 2017 Jan;48(1):167-173. doi: 10.1161/STROKEAHA.116.014891. Epub 2016 Nov 29.

Abstract

Background and purpose: In the SOCRATES trial (Acute Stroke or Transient Ischemic Attack Treated With Aspirin or Ticagrelor and Patient Outcomes), ticagrelor was not superior to aspirin. Because of differences in patient demographics and stroke disease pattern in Asia, outcomes of ticagrelor versus aspirin were assessed among Asian patients in a prespecified exploratory analysis.

Methods: Baseline demographics, treatment effects, and safety of ticagrelor and aspirin were assessed among Asian patients. Differences in outcomes between groups were assessed using Cox proportional hazard model.

Results: A total of 3858 (29.2%) SOCRATES participants were recruited in Asia. Among the Asian patients, the primary end point event occurred in 186 (9.6%) of the 1933 patients treated with ticagrelor, versus 224 (11.6%) of the 1925 patients treated with aspirin (hazard ratio, 0.81; 95% confidence interval, 0.67-0.99). The exploratory P value for treatment-by-region interaction was 0.27. The primary end point event rate in the Asian subgroup was numerically higher than that in the non-Asian group (10.6% versus 5.7%; nominal P<0.01). Among the Asian patients, the rate of PLATO (Platelet Inhibition and Patient Outcomes)-defined major bleeding was similar in the ticagrelor group and the aspirin group (0.6% versus 0.8%; hazard ratio, 0.76; 95% confidence interval, 0.36-1.61).

Conclusions: The event rates were numerically higher in the Asian patients. Among the Asian patients with acute stroke or transient ischemic attacks, there was a trend toward a lower hazard ratio in reducing risk of the primary end point of stroke, myocardial infarction, or death in the ticagrelor group.

Clinical trial registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01994720.

Keywords: Asian continental ancestry group; aspirin; myocardial infarction; stroke; ticagrelor.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adenosine / adverse effects
  • Adenosine / analogs & derivatives*
  • Adenosine / therapeutic use
  • Aged
  • Anti-Inflammatory Agents, Non-Steroidal / adverse effects
  • Anti-Inflammatory Agents, Non-Steroidal / therapeutic use
  • Asians*
  • Aspirin / adverse effects
  • Aspirin / therapeutic use*
  • Cohort Studies
  • Double-Blind Method
  • Female
  • Hemorrhage / chemically induced
  • Humans
  • Ischemic Attack, Transient / diagnosis
  • Ischemic Attack, Transient / drug therapy*
  • Ischemic Attack, Transient / epidemiology
  • Male
  • Middle Aged
  • Purinergic P2Y Receptor Antagonists / adverse effects
  • Purinergic P2Y Receptor Antagonists / therapeutic use
  • Stroke / diagnosis
  • Stroke / drug therapy*
  • Stroke / epidemiology
  • Ticagrelor
  • Treatment Outcome

Substances

  • Anti-Inflammatory Agents, Non-Steroidal
  • Purinergic P2Y Receptor Antagonists
  • Ticagrelor
  • Adenosine
  • Aspirin

Associated data

  • ClinicalTrials.gov/NCT01994720