PMID- 29488142 OWN - NLM STAT- MEDLINE DCOM- 20190129 LR - 20240314 IS - 1573-7241 (Electronic) IS - 0920-3206 (Print) IS - 0920-3206 (Linking) VI - 32 IP - 1 DP - 2018 Feb TI - Safety and Incidence of Cardiovascular Events in Chinese Patients with Acute Coronary Syndrome Treated with Ticagrelor: the 12-Month, Phase IV, Multicenter, Single-Arm DAYU Study. PG - 47-56 LID - 10.1007/s10557-018-6772-3 [doi] AB - PURPOSE: Ticagrelor is an orally administered, reversibly binding, direct-acting P2Y(12) receptor antagonist previously evaluated in several phase III trials. This phase IV, multicenter, single-arm trial assessed the safety and incidence of cardiovascular (CV) events with ticagrelor in Chinese patients experiencing an acute coronary syndrome (ACS). METHODS: Patients hospitalized with an ACS received ticagrelor (180 mg loading dose, 90 mg twice daily thereafter) plus low-dose aspirin (75-100 mg/day) for up to 12 months. Safety was evaluated via PLATO-defined bleeding events, adverse events (AEs), serious AEs, and laboratory measurements. The incidence of major CV events was also evaluated. RESULTS: The safety population included 2001 patients. During ticagrelor treatment, 426 (21.3%) patients had at least one PLATO-defined bleeding AE, mainly minimal bleedings (n = 333). Major bleeding events occurred in 27 (1.3%) patients, including fatal/life-threatening bleeding in 17 (0.8%) patients and other major bleeding in 11 (0.5%) patients, with a Kaplan-Meier estimate of patients with the event (95% CI) of 1.6% (1.1-2.3%). In total, 784 (39.2%) patients had at least one non-bleeding AE, the majority of which were mild in severity. The composite endpoint of CV death, myocardial infarction, and stroke occurred in 83 (4.1%) patients. CONCLUSIONS: Ticagrelor plus low-dose aspirin for up to 1 year was associated with a low rate of major bleeding events and a low incidence of major CV events (CV death, myocardial infarction, stroke) in Chinese patients with ACS. The overall safety profile of ticagrelor in this population was in line with current prescribing information. FAU - Gao, Runlin AU - Gao R AD - Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, 167 Beilishi Road, Xi Cheng District, Beijing, China. gaorunlin@citmd.com. FAU - Wu, Yongjian AU - Wu Y AD - Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, 167 Beilishi Road, Xi Cheng District, Beijing, China. FAU - Liu, Hengliang AU - Liu H AD - Zhengzhou People Hospital, Zhengzhou, China. FAU - Su, Guohai AU - Su G AD - Jinan Central Hospital, Jinan, China. FAU - Yuan, Zuyi AU - Yuan Z AD - First Affiliated Hospital of Medical College of Xi'An Jiaotong University, Xi'an, China. FAU - Zhang, Aidong AU - Zhang A AD - The First Affiliated Hospital of Jinan University, Guangzhou, China. FAU - Wang, Yong AU - Wang Y AD - China-Japan Friendship Hospital, Beijing, China. FAU - Wang, Zhirong AU - Wang Z AD - The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China. FAU - Wang, Yan AU - Wang Y AD - Xiamen Heart Center, Xiamen, China. FAU - Zhang, Huanyi AU - Zhang H AD - The Central Hospital of Tai'an, Tai'an, China. FAU - Zheng, Yang AU - Zheng Y AD - The First Hospital of Jilin University, Changchun, China. FAU - Liu, Lei AU - Liu L AD - AstraZeneca China, Shanghai, China. FAU - Shen, Lijun AU - Shen L AD - AstraZeneca China, Shanghai, China. FAU - Leonsson-Zachrisson, Maria AU - Leonsson-Zachrisson M AD - AstraZeneca R&D, Molndal, Sweden. FAU - Han, Yaling AU - Han Y AD - The General Hospital of Shenyang Military Region, Shenyang, China. CN - DAYU study investigators LA - eng PT - Clinical Trial, Phase IV PT - Journal Article PT - Multicenter Study PL - United States TA - Cardiovasc Drugs Ther JT - Cardiovascular drugs and therapy JID - 8712220 RN - 0 (Platelet Aggregation Inhibitors) RN - GLH0314RVC (Ticagrelor) RN - R16CO5Y76E (Aspirin) SB - IM MH - Acute Coronary Syndrome/diagnosis/*drug therapy/mortality MH - Adult MH - Aged MH - Aged, 80 and over MH - Aspirin/administration & dosage MH - China/epidemiology MH - Drug Therapy, Combination MH - Female MH - Hemorrhage/chemically induced/mortality MH - Humans MH - Incidence MH - Male MH - Middle Aged MH - Myocardial Infarction/diagnosis/mortality/*prevention & control MH - Platelet Aggregation Inhibitors/*administration & dosage/adverse effects MH - Risk Factors MH - Stroke/diagnosis/mortality/*prevention & control MH - Ticagrelor/*administration & dosage/adverse effects MH - Time Factors MH - Treatment Outcome PMC - PMC5843700 OTO - NOTNLM OT - Acute coronary syndrome OT - Chinese patients OT - Safety OT - Ticagrelor COIS- CONFLICT OF INTEREST: RG received a research grant from AstraZeneca. HL, YWu, GS, Yan W, ZW, HZ, AZ, YZ, Yong W, ZY, and YH declare no conflicts of interest. LL and ML-Z are current employees of AstraZeneca. LS was an employee of AstraZeneca when the study was conducted. ETHICAL APPROVAL: The study was conducted in accordance with the Declaration of Helsinki and the International Conference on Harmonization/Good Clinical Practice Guidelines, and followed applicable regulatory requirements including AstraZeneca's policy on bioethics. The local Institutional Review Boards or Independent Ethics Committees approved the final protocol and amendment. Written informed consent was obtained from all patients. FIR - Miao, Wei IR - Miao W FIR - Geng, Guoying IR - Geng G FIR - Han, Wenjie IR - Han W FIR - Wu, Lei IR - Wu L EDAT- 2018/03/01 06:00 MHDA- 2019/01/30 06:00 PMCR- 2018/02/28 CRDT- 2018/03/01 06:00 PHST- 2018/03/01 06:00 [pubmed] PHST- 2019/01/30 06:00 [medline] PHST- 2018/03/01 06:00 [entrez] PHST- 2018/02/28 00:00 [pmc-release] AID - 10.1007/s10557-018-6772-3 [pii] AID - 6772 [pii] AID - 10.1007/s10557-018-6772-3 [doi] PST - ppublish SO - Cardiovasc Drugs Ther. 2018 Feb;32(1):47-56. doi: 10.1007/s10557-018-6772-3.