Evidence map›Paper›PMID 29488142›Full record

Trial reportCardiovascular drugs and therapy2018

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.

Runlin Gao, Yongjian Wu, Hengliang Liu, Guohai Su, Zuyi Yuan, Aidong Zhang, Yong Wang, Zhirong Wang, Yan Wang, Huanyi Zhang and 6 more

Registry-linked trialAbstract readClinical Trial, Phase IVMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cardiovascular drugs and therapy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01870921 (A Multicenter, Single Arm, Open Label, Phase IV Study to Evaluate Safety and to Describe the Incidence of Major Cardiovascular Events of Ticagrelor in Chinese Patients With Acute Coronary Syndrome), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01870921 phase4completednot on this map

A Multicenter, Single Arm, Open Label, Phase IV Study to Evaluate Safety and to Describe the Incidence of Major Cardiovascular Events of Ticagrelor in Chinese Patients With Acute Coronary Syndrome(ACS)

TypeinterventionalSponsorAstraZenecaRan2013 to 2015Enrolled2,004ConditionsAcute Coronary SyndromeArmsTicagrelor
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Runlin GaoFuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, 167 Beilishi Road, Xi Cheng District, Beijing, China. gaorunlin@citmd.com.
Yongjian WuFuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, 167 Beilishi Road, Xi Cheng District, Beijing, China.
Hengliang LiuZhengzhou People Hospital, Zhengzhou, China.
Guohai SuJinan Central Hospital, Jinan, China.
Zuyi YuanFirst Affiliated Hospital of Medical College of Xi'An Jiaotong University, Xi'an, China.
Aidong ZhangThe First Affiliated Hospital of Jinan University, Guangzhou, China.
Yong WangChina-Japan Friendship Hospital, Beijing, China.
Zhirong WangThe Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.
Yan WangXiamen Heart Center, Xiamen, China.
Huanyi ZhangThe Central Hospital of Tai'an, Tai'an, China.
Yang ZhengThe First Hospital of Jilin University, Changchun, China.
Lei LiuAstraZeneca China, Shanghai, China.
Lijun ShenAstraZeneca China, Shanghai, China.
Maria Leonsson-ZachrissonAstraZeneca R&D, Mölndal, Sweden.
Yaling HanThe General Hospital of Shenyang Military Region, Shenyang, China.
DAYU study investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTicagrelor is an orally administered, reversibly binding, direct-acting P2Y

methodsPatients 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.

resultsThe 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.

conclusionsTicagrelor 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.

Indexed as

Acute Coronary SyndromeAdultAgedAged, 80 and overAspirinChinaDrug Therapy, CombinationFemaleHemorrhageHumansIncidenceMaleMiddle AgedMyocardial InfarctionPlatelet Aggregation InhibitorsRisk FactorsAspirinPlatelet Aggregation InhibitorsTicagrelorAcute coronary syndromeChinese patientsSafetyTicagrelor

Identifiers

PMID29488142
PMCPMC5843700

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.