Clopidogrel and Aspirin in Acute Ischemic Stroke and High-Risk TIA
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Clopidogrel and Aspirin in Acute Ischemic Stroke and High-Risk TIA. / Johnston, S Claiborne; Easton, J Donald; Farrant, Mary; Barsan, William; Conwit, Robin A; Elm, Jordan J; Kim, Anthony S; Lindblad, Anne S; Palesch, Yuko Y; Clinical Research Collaboration, Neurological Emergencies Treatment Trials Network, and the POINT Investigators.
in: NEW ENGL J MED, Jahrgang 379, Nr. 3, 19.07.2018, S. 215-225.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Clopidogrel and Aspirin in Acute Ischemic Stroke and High-Risk TIA
AU - Johnston, S Claiborne
AU - Easton, J Donald
AU - Farrant, Mary
AU - Barsan, William
AU - Conwit, Robin A
AU - Elm, Jordan J
AU - Kim, Anthony S
AU - Lindblad, Anne S
AU - Palesch, Yuko Y
AU - Clinical Research Collaboration, Neurological Emergencies Treatment Trials Network, and the POINT Investigators
PY - 2018/7/19
Y1 - 2018/7/19
N2 - BACKGROUND: Combination antiplatelet therapy with clopidogrel and aspirin may reduce the rate of recurrent stroke during the first 3 months after a minor ischemic stroke or transient ischemic attack (TIA). A trial of combination antiplatelet therapy in a Chinese population has shown a reduction in the risk of recurrent stroke. We tested this combination in an international population.METHODS: In a randomized trial, we assigned patients with minor ischemic stroke or high-risk TIA to receive either clopidogrel at a loading dose of 600 mg on day 1, followed by 75 mg per day, plus aspirin (at a dose of 50 to 325 mg per day) or the same range of doses of aspirin alone. The dose of aspirin in each group was selected by the site investigator. The primary efficacy outcome in a time-to-event analysis was the risk of a composite of major ischemic events, which was defined as ischemic stroke, myocardial infarction, or death from an ischemic vascular event, at 90 days.RESULTS: A total of 4881 patients were enrolled at 269 international sites. The trial was halted after 84% of the anticipated number of patients had been enrolled because the data and safety monitoring board had determined that the combination of clopidogrel and aspirin was associated with both a lower risk of major ischemic events and a higher risk of major hemorrhage than aspirin alone at 90 days. Major ischemic events occurred in 121 of 2432 patients (5.0%) receiving clopidogrel plus aspirin and in 160 of 2449 patients (6.5%) receiving aspirin plus placebo (hazard ratio, 0.75; 95% confidence interval [CI], 0.59 to 0.95; P=0.02), with most events occurring during the first week after the initial event. Major hemorrhage occurred in 23 patients (0.9%) receiving clopidogrel plus aspirin and in 10 patients (0.4%) receiving aspirin plus placebo (hazard ratio, 2.32; 95% CI, 1.10 to 4.87; P=0.02).CONCLUSIONS: In patients with minor ischemic stroke or high-risk TIA, those who received a combination of clopidogrel and aspirin had a lower risk of major ischemic events but a higher risk of major hemorrhage at 90 days than those who received aspirin alone. (Funded by the National Institute of Neurological Disorders and Stroke; POINT ClinicalTrials.gov number, NCT00991029 .).
AB - BACKGROUND: Combination antiplatelet therapy with clopidogrel and aspirin may reduce the rate of recurrent stroke during the first 3 months after a minor ischemic stroke or transient ischemic attack (TIA). A trial of combination antiplatelet therapy in a Chinese population has shown a reduction in the risk of recurrent stroke. We tested this combination in an international population.METHODS: In a randomized trial, we assigned patients with minor ischemic stroke or high-risk TIA to receive either clopidogrel at a loading dose of 600 mg on day 1, followed by 75 mg per day, plus aspirin (at a dose of 50 to 325 mg per day) or the same range of doses of aspirin alone. The dose of aspirin in each group was selected by the site investigator. The primary efficacy outcome in a time-to-event analysis was the risk of a composite of major ischemic events, which was defined as ischemic stroke, myocardial infarction, or death from an ischemic vascular event, at 90 days.RESULTS: A total of 4881 patients were enrolled at 269 international sites. The trial was halted after 84% of the anticipated number of patients had been enrolled because the data and safety monitoring board had determined that the combination of clopidogrel and aspirin was associated with both a lower risk of major ischemic events and a higher risk of major hemorrhage than aspirin alone at 90 days. Major ischemic events occurred in 121 of 2432 patients (5.0%) receiving clopidogrel plus aspirin and in 160 of 2449 patients (6.5%) receiving aspirin plus placebo (hazard ratio, 0.75; 95% confidence interval [CI], 0.59 to 0.95; P=0.02), with most events occurring during the first week after the initial event. Major hemorrhage occurred in 23 patients (0.9%) receiving clopidogrel plus aspirin and in 10 patients (0.4%) receiving aspirin plus placebo (hazard ratio, 2.32; 95% CI, 1.10 to 4.87; P=0.02).CONCLUSIONS: In patients with minor ischemic stroke or high-risk TIA, those who received a combination of clopidogrel and aspirin had a lower risk of major ischemic events but a higher risk of major hemorrhage at 90 days than those who received aspirin alone. (Funded by the National Institute of Neurological Disorders and Stroke; POINT ClinicalTrials.gov number, NCT00991029 .).
KW - Aged
KW - Aspirin
KW - Brain Ischemia
KW - Double-Blind Method
KW - Drug Therapy, Combination
KW - Female
KW - Hemorrhage
KW - Humans
KW - Ischemia
KW - Ischemic Attack, Transient
KW - Male
KW - Middle Aged
KW - Myocardial Infarction
KW - Platelet Aggregation Inhibitors
KW - Risk
KW - Secondary Prevention
KW - Stroke
KW - Ticlopidine
KW - Journal Article
KW - Multicenter Study
KW - Randomized Controlled Trial
KW - Research Support, N.I.H., Extramural
KW - Research Support, Non-U.S. Gov't
U2 - 10.1056/NEJMoa1800410
DO - 10.1056/NEJMoa1800410
M3 - SCORING: Journal article
C2 - 29766750
VL - 379
SP - 215
EP - 225
JO - NEW ENGL J MED
JF - NEW ENGL J MED
SN - 0028-4793
IS - 3
ER -