A planned randomized controlled trial of 2,382 patients will evaluate whether individualized antiplatelet therapy based on pharmacogenomics reduces new stroke events at 1 year in AIMS or TIA.
RCT (n=2,382)
1:1
Does individualized antiplatelet therapy based on pharmacogenomics reduce new stroke events compared to standard care in patients with acute ischaemic minor stroke or TIA?
This study protocol outlines a randomized trial to determine if pharmacogenomic-guided antiplatelet therapy improves clinical outcomes compared to standard care in patients with acute ischemic minor stroke or TIA.
INTRODUCTION: Antiplatelet therapy combining aspirin and clopidogrel is considered to be a key intervention for acute ischaemic minor stroke (AIMS) and transient ischaemic attack (TIA). However, the interindividual variability in response to clopidogrel resulting from the polymorphisms in clopidogrel metabolism-related genes has greatly limited its efficacy. To date, there are no reports on individualised antiplatelet therapy for AIMS and TIA based on the genetic testing and clinical features. Therefore, we conduct this randomised controlled trial to validate the hypothesis that the individualised antiplatelet therapy selected on the basis of a combination of genetic information and clinical features would lead to better clinical outcomes compared with the standard care based only on clinical features in patients with AIMS or TIA. METHODS AND ANALYSIS: This trial will recruit 2382 patients with AIMS or TIA who meet eligibility criteria. Patients are randomly assigned in a 1:1 ratio to pharmacogenetic group and standard group. Both groups receive a loading dose of 300 mg aspirin and 300 mg clopidogrel on day 1, followed by 100 mg aspirin per day on days 2-365. The P2Y12 receptor antagonist is selected by the clinician according to the genetic information and clinical features for pharmacogenetic group and clinical features for the standard group on days 2-21. The primary efficacy endpoint is a new stroke event (ischaemic or haemorrhagic) that happens within 1 year. The secondary efficacy endpoint is analysed as the individual or composite outcomes of the new clinical vascular event (ischaemic stroke, haemorrhagic stroke, myocardial infarction or vascular death). Baseline characteristics and outcomes after treatment will be evaluated. ETHICS AND DISSEMINATION: This protocol has been approved by the ethics committee of Yangpu Hospital, Tongji University School of Medicine (No. LL-2018-KY-012). We will submit the results of this trial for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: ChiCTR1800019911; Pre-results.
Zhang et al. (Wed,) conducted a rct in Acute ischaemic minor stroke and transient ischaemic attack (n=2,382). Individualised antiplatelet therapy based on pharmacogenomics and clinical features vs. Standard care based only on clinical features was evaluated on New stroke event (ischaemic or haemorrhagic) within 1 year. A planned randomized controlled trial of 2,382 patients will evaluate whether individualized antiplatelet therapy based on pharmacogenomics reduces new stroke events at 1 year in AIMS or TIA.