title: Effect of ticagrelor with clopidogrel on high on-treatment platelet reactivity in acute stroke or transient ischemic attack (PRINCE) trial: Rationale and design.
abstract: Rationale and aim Little is known about the safety and efficacy of the combination of ticagrelor and aspirin in acute ischemic stroke. This study aimed to evaluate whether the combination of ticagrelor and aspirin was superior to that of clopidogrel and aspirin in reducing the 90-day high on-treatment platelet reactivity for acute minor stroke or transient ischemic attack, especially for carriers of cytochrome P450 2C19 loss-of-function allele. Sample size and design This study was designed as a prospective, multicenter, randomized, open-label, active-controlled, and blind-endpoint, phase II b trial. The required sample size was 952 patients. It was registered with ClinicalTrials.gov (NCT02506140). Study outcomes The primary outcome was the proportion of patients with high on-treatment platelet reactivity at 90 days. High on-treatment platelet reactivity is defined as the P2Y12 reaction unit >208 measured using the VerifyNow P2Y12 assay. Conclusion The Platelet Reactivity in Acute Non-disabling Cerebrovascular Events study explored whether ticagrelor combined with aspirin could reduce further the proportion of patients with high on-treatment platelet reactivity at 90 days after acute minor stroke or transient ischemic attack compared with clopidogrel and aspirin.
authors.affiliation: 1 Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.|2 China National Clinical Research Center for Neurological Diseases, Beijing, China.|3 Center of Stroke, Beijing Institute for Brain Disorders, Beijing, China.|4 Beijing Key Laboratory of Translational Medicine for Cerebrovascular Disease, Beijing, China.
authors.forename: Yilong
authors.initials: Y
authors.lastname: Wang
authors.affiliation: 5 Department of Neurology and Institute of Neurology, First Affiliated Hospital, Fujian Medical University, Fuzhou, China.
authors.forename: Yi
authors.initials: Y
authors.lastname: Lin
authors.affiliation: 1 Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.|2 China National Clinical Research Center for Neurological Diseases, Beijing, China.|3 Center of Stroke, Beijing Institute for Brain Disorders, Beijing, China.|4 Beijing Key Laboratory of Translational Medicine for Cerebrovascular Disease, Beijing, China.
authors.forename: Xia
authors.initials: X
authors.lastname: Meng
authors.affiliation: 1 Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.|2 China National Clinical Research Center for Neurological Diseases, Beijing, China.|3 Center of Stroke, Beijing Institute for Brain Disorders, Beijing, China.|4 Beijing Key Laboratory of Translational Medicine for Cerebrovascular Disease, Beijing, China.
authors.forename: Weiqi
authors.initials: W
authors.lastname: Chen
authors.affiliation: 6 Department of Neurology, Wuhan No.1 Hospital, Wuhan, China.
authors.forename: Guohua
authors.initials: G
authors.lastname: Chen
authors.affiliation: 7 Department of Neurology, Taizhou First People's Hospital, Huangyan Hospital of Wenzhou Medical University, Taizhou, China.
authors.forename: Zhimin
authors.initials: Z
authors.lastname: Wang
authors.affiliation: 8 Department of Neurology, Tianjin Huanhu Hospital, Tianjin, China.
authors.forename: Jialing
authors.initials: J
authors.lastname: Wu
authors.affiliation: 9 Department of Neurology, North China University of Science and Technology Affiliated Hospital, Tangshan, China.
authors.forename: Dali
authors.initials: D
authors.lastname: Wang
authors.affiliation: 10 Department of Neurology, The First Hospital of Fangshan District, Beijing, China.
authors.forename: Jianhua
authors.initials: J
authors.lastname: Li
authors.affiliation: 11 Department of Neurology, Tangshan Gongren Hospital, Tangshan, China.
authors.forename: Yibin
authors.initials: Y
authors.lastname: Cao
authors.affiliation: 12 Department of Neurology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
authors.forename: Yuming
authors.initials: Y
authors.lastname: Xu
authors.affiliation: 13 Department of Neurology, the Second Hospital of Hebei Medical University, Shijiazhuang, China.
authors.forename: Guohua
authors.initials: G
authors.lastname: Zhang
authors.affiliation: 14 Department of Neurology, Northern Jiangsu People's Hospital, Clinical Medical School, Yangzhou University, Yangzhou, China.
authors.forename: Xiaobo
authors.initials: X
authors.lastname: Li
authors.affiliation: 1 Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.|2 China National Clinical Research Center for Neurological Diseases, Beijing, China.|3 Center of Stroke, Beijing Institute for Brain Disorders, Beijing, China.|4 Beijing Key Laboratory of Translational Medicine for Cerebrovascular Disease, Beijing, China.
authors.forename: Yuesong
authors.initials: Y
authors.lastname: Pan
authors.affiliation: 1 Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.|2 China National Clinical Research Center for Neurological Diseases, Beijing, China.|3 Center of Stroke, Beijing Institute for Brain Disorders, Beijing, China.|4 Beijing Key Laboratory of Translational Medicine for Cerebrovascular Disease, Beijing, China.
authors.forename: Hao
authors.initials: H
authors.lastname: Li
authors.affiliation: 1 Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.|2 China National Clinical Research Center for Neurological Diseases, Beijing, China.|3 Center of Stroke, Beijing Institute for Brain Disorders, Beijing, China.|4 Beijing Key Laboratory of Translational Medicine for Cerebrovascular Disease, Beijing, China.
authors.forename: Liping
authors.initials: L
authors.lastname: Liu
authors.affiliation: 1 Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.|2 China National Clinical Research Center for Neurological Diseases, Beijing, China.|3 Center of Stroke, Beijing Institute for Brain Disorders, Beijing, China.|4 Beijing Key Laboratory of Translational Medicine for Cerebrovascular Disease, Beijing, China.
authors.forename: Xingquan
authors.initials: X
authors.lastname: Zhao
authors.affiliation: 1 Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.|2 China National Clinical Research Center for Neurological Diseases, Beijing, China.|3 Center of Stroke, Beijing Institute for Brain Disorders, Beijing, China.|4 Beijing Key Laboratory of Translational Medicine for Cerebrovascular Disease, Beijing, China.
authors.forename: Yongjun
authors.initials: Y
authors.lastname: Wang
mesh_terms: D000241:Adenosine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D001792:Blood Platelets / Q000187:drug effects; D000077144:Clopidogrel; D065731:Cytochrome P-450 CYP2C19 / Q000235:genetics; D004359:Drug Therapy, Combination; D006579:Heterozygote; D006801:Humans; D002546:Ischemic Attack, Transient / Q000097:blood / Q000188:drug therapy* / Q000235:genetics / Q000401:mortality; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D058921:Purinergic P2Y Receptor Antagonists / Q000627:therapeutic use*; D012107:Research Design; D020521:Stroke / Q000097:blood / Q000188:drug therapy* / Q000235:genetics / Q000401:mortality; D000077486:Ticagrelor; D013988:Ticlopidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D010975:Platelet Aggregation Inhibitors; D058921:Purinergic P2Y Receptor Antagonists; D000077144:Clopidogrel; C045793:CYP2C19 protein, human; D065731:Cytochrome P-450 CYP2C19; D000077486:Ticagrelor; D000241:Adenosine; D013988:Ticlopidine
keywords: Clopidogrel; minor stroke; platelet reactivity; protocol; ticagrelor; transient ischemic attack