In 2013, the CHANCE trial found a 32% lower risk of stroke recurrence at 90 days by using a combination of clopidogrel and aspirin, as compared to aspirin alone, in a Chinese sample. This study, the Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) trial was designed to generalize these results to the international population.
METHODSThis randomized, double-blind, placebo-controlled trial enrolled 4,881 patients from 10 countries. Patients with NIHSS stroke scores of less than three were randomized within 12 hours after an acute ischemic stroke. The treatment group received a loading dose of clopidogrel 600mg, followed by 75mg daily, in addition to aspirin for 90 days for the duration of the study. The control group received aspirin plus placebo. The primary efficacy outcome measure was the risk of a composite of ischemic stroke, myocardial infarction and death from ischemic vascular causes. The primary safety outcome variable was the risk of major hemorrhage.
RESULTSAfter 90 days, five percent of the patients who received combination therapy and 6.5% who received aspirin monotherapy achieved the primary efficacy outcome (P=0.02). Major hemorrhage occurred in 0.9% of the combination group and in 0.4% in aspirin group (P=0.02), with nonfatal, extracranial hemorrhage accounting for most of the hemorrhages. The risk of ischemic or hemorrhagic stroke was greater in the aspirin group than in the combination group (P=0.01).
CONCLUSIONThis international study of patients who had sustained an acute ischemic stroke found that combining aspirin and clopidogrel reduces the risk of ischemic stroke, myocardial infarction or death from ischemic vascular causes while increasing the risk of major hemorrhage.