Platelet function monitoring in elderly patients on prasugrel after stenting for an acute coronary syndrome: design of the randomized antarctic study

Am Heart J. 2014 Nov;168(5):674-81. doi: 10.1016/j.ahj.2014.07.026. Epub 2014 Aug 7.

Abstract

Background: Elderly patients are at high risk for both ischemic and bleeding events. Platelet monitoring offers the opportunity to individualized antiplatelet therapy to optimize the therapeutic risk/benefit ratio.

Study design: The ANTARCTIC study is designed to demonstrate the superiority of a strategy of platelet function monitoring with dose and drug adjustment in patients initially on prasugrel 5 mg as compared with a more conventional strategy using prasugrel 5 mg without monitoring and without adjustment (Conventional Treatment Arm) to reduce the primary end point evaluated 1 year after stent percutaneous coronary intervention in elderly patients presenting with an acute coronary syndrome (ACS). ANTARCTIC is a multicenter, prospective, open-label study with 2 parallel arms. A total of 852 elderly patients (≥ 75 years) undergoing stent percutaneous coronary intervention for ACS are to be enrolled. The primary end point is the time to first occurrence of cardiovascular death, myocardial infarction, stroke, definite stent thrombosis, urgent revascularization, and bleeding complications (Bleeding Academic Research Consortium definition 2, 3, or 5). Platelet function analyses will be performed 14 days after randomization and repeated 14 days later in patients who require a change in treatment.

Conclusion: ANTARCTIC is a nationwide, prospective, open-label study testing a strategy of platelet function monitoring with dose and drug adjustment to reduce ischemic and bleeding complications in elderly ACS patients undergoing coronary stenting.

Trial registration: ClinicalTrials.gov NCT01538446.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Acute Coronary Syndrome / therapy*
  • Aged
  • Aged, 80 and over
  • Dose-Response Relationship, Drug
  • Drug Monitoring / methods*
  • Hemorrhage / prevention & control*
  • Humans
  • Myocardial Ischemia / prevention & control*
  • Percutaneous Coronary Intervention*
  • Piperazines / therapeutic use*
  • Platelet Function Tests
  • Prasugrel Hydrochloride
  • Purinergic P2Y Receptor Antagonists / therapeutic use*
  • Stents*
  • Thiophenes / therapeutic use*
  • Treatment Outcome

Substances

  • Piperazines
  • Purinergic P2Y Receptor Antagonists
  • Thiophenes
  • Prasugrel Hydrochloride

Associated data

  • ClinicalTrials.gov/NCT01538446