Evaluation on the Safety of Ticagrelor Among Chinese ACS Patients

The primary objective is to describe the safety and tolerability of ticagrelor, by assessment of adverse events (characteristics, reporting rate, severity, relationship and risk factors), especially the bleeding events as defined in 8.1 and other serious adverse events (SAEs) during 1-year follow up in Chinese acute coronary syndrome (ACS) patients.

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Key information

Conditions

Acute Coronary Syndrome (ACS) Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–130 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Beijing, China

About this study

The trial is a multi-centre, prospective cohort, non-interventional study to be conducted in the department of cardiology from approximately 20 tier-2 or 3 hospitals, China. The study requires Chinese subjects aged over 18, diagnosed as ACS and treated with ticagrelor at least one tablet from the department of cardiology in the around 20 tier-2 or 3 hospitals. The subjects will be tracked up to 1 month after the discontinuation of ticagrelor for AE events and 1 year after enrollment for major cardiovascular events. This is an observational study. The prescribing doctor is in charge of prescribing or discontinuation ticagrelor. The investigator in an observational study may not intervene in the treatment. All 1000 subjects' related data will be collected

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

1. Provision of informed consent prior to any study specific procedures 2. Chinese female or male aged at least 18 years 3. Index event of non-ST or ST segment elevation ACS. 4. Taken with ticagrelor at least one tablet before enrollment.

Exclusion criteria

-1. Participation in another clinical study with an investigational product during the last 6 months.

Previous enrolment in the present study; 3. Allergy or any other contraindication to ticagrelor as described in ticagrelor China PI.

Treatment and study plan

Primary outcomes

Safety and tolerability of ticagrelor, by assessment of adverse events, especially the bleeding events and other SAEs during 1-year follow up in Chinese ACS patients.

Time frame: 1 year

a) Incidence of post-authorization adverse events including characteristics, reporting rate, severity, relationship and risk factors among Chinese ACS patients with ticagrelor during 1-year follow up b) PLATO-defined fatal/life-threatening bleedings during 1-year follow up in Chinese ACS patients treated with ticagrelor. c) PLATO-defined major bleedings during 1-year follow up in Chinese ACS patients treated with ticagrelor. d) PLATO-defined major + minor bleedings during 1-year follow up in Chinese ACS patients treated with ticagrelor. e) PLATO-defined major + minor + minimal bleedings during 1-year follow up in Chinese ACS patients treated with ticagrelor. f) Serious adverse events other than bleeding during 1-year follow up in Chinese ACS patients treated with ticagrelor

Secondary outcomes

Incidence of major cardiovascular (CV) events during 1-year follow up in Chinese ACS patients treated with ticagrelor.

Time frame: 1 year

Major CV events including CV death, MI and Stroke, during 1 year follow up in Chinese ACS patients treated with ticagrelor. Incidence of post-authorization adverse events among specific patients groups from Chinese ACS patients with ticagrelor. Survival free of major CV events among Chinese ACS patients with ticagrelor. Proportion of patients with discontinuation or interruption of ticagrelor and the reasons.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Multi-Centre, Prospective Cohort, Non-Interventional Study About Evaluation on the Safety of Ticagrelor Among Chinese ACS Patients

Acronym: YingLong

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: Apr 30, 2015
Registry last updated: Mar 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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