2018 July 19; 379(3): 215–225 | S. Claiborne Johnston, M.D., Ph.D., J. Donald Easton, M.D., Mary Farrant, M.B.A., William Barsan, M.D., Robin A. Conwit, M.D., Jordan J. Elm, Ph.D., Anthony S. Kim, M.D., Anne S. Lindblad, Ph.D., Yuko Y. Palesch, Ph.D., and Clinical Research Collaboration, Neurological Emergencies Treatment Trials Network, and the POINT Investigators
The POINT (Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke) trial evaluated the effectiveness and safety of clopidogrel plus aspirin compared to aspirin alone in patients with minor ischemic stroke or high-risk transient ischemic attack (TIA). The trial was conducted internationally, enrolling 4881 patients across 269 sites in 10 countries. Patients were randomly assigned to receive either clopidogrel plus aspirin or aspirin alone, with the dose of aspirin selected by the site investigator. The primary efficacy outcome was a composite of ischemic stroke, myocardial infarction, or death from ischemic vascular causes at 90 days. The primary safety outcome was major hemorrhage.
The trial was halted after enrolling 84% of the anticipated number of patients due to a significant excess of major hemorrhages in the clopidogrel plus aspirin group. Despite this, the clopidogrel plus aspirin group had a lower risk of major ischemic events (hazard ratio, 0.75; 95% CI, 0.59 to 0.95; P = 0.02) compared to the aspirin alone group. However, the risk of major hemorrhage was higher in the clopidogrel plus aspirin group (hazard ratio, 2.32; 95% CI, 1.10 to 4.87; P = 0.02).
The results suggest that while clopidogrel plus aspirin reduces the risk of major ischemic events, it also increases the risk of major hemorrhage in patients with minor ischemic stroke or high-risk TIA. The trial highlights the need for careful consideration of the benefits and risks when using this combination therapy.The POINT (Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke) trial evaluated the effectiveness and safety of clopidogrel plus aspirin compared to aspirin alone in patients with minor ischemic stroke or high-risk transient ischemic attack (TIA). The trial was conducted internationally, enrolling 4881 patients across 269 sites in 10 countries. Patients were randomly assigned to receive either clopidogrel plus aspirin or aspirin alone, with the dose of aspirin selected by the site investigator. The primary efficacy outcome was a composite of ischemic stroke, myocardial infarction, or death from ischemic vascular causes at 90 days. The primary safety outcome was major hemorrhage.
The trial was halted after enrolling 84% of the anticipated number of patients due to a significant excess of major hemorrhages in the clopidogrel plus aspirin group. Despite this, the clopidogrel plus aspirin group had a lower risk of major ischemic events (hazard ratio, 0.75; 95% CI, 0.59 to 0.95; P = 0.02) compared to the aspirin alone group. However, the risk of major hemorrhage was higher in the clopidogrel plus aspirin group (hazard ratio, 2.32; 95% CI, 1.10 to 4.87; P = 0.02).
The results suggest that while clopidogrel plus aspirin reduces the risk of major ischemic events, it also increases the risk of major hemorrhage in patients with minor ischemic stroke or high-risk TIA. The trial highlights the need for careful consideration of the benefits and risks when using this combination therapy.