NCT02430493

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,066

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 30, 2015

Completed
28 days until next milestone

Study Start

First participant enrolled

May 28, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2017

Completed
Last Updated

March 14, 2018

Status Verified

March 1, 2018

Enrollment Period

1.8 years

First QC Date

April 27, 2015

Last Update Submit

March 12, 2018

Conditions

Acute Coronary Syndrome (ACS)

Keywords

ACS

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    1 year

Secondary Outcomes (1)

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

    1 year

Study Arms (1)

ticagrelor

Chinese subjects aged over 18, diagnosed as ACS and treated with ticagrelor at least one tablet

Eligibility Criteria

Age18 Years - 130 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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.

You may qualify if:

  • \. 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Research Site

Beijing, China

Location

Research Site

Changchun, China

Location

Research Site

Changsha, China

Location

Research Site

Dalian, China

Location

Research Site

Guangzhou, China

Location

Research Site

Huai'an, China

Location

Research Site

Jinan, China

Location

Research Site

Nanjing, China

Location

Research Site

Shanghai, China

Location

Research Site

Shenzhen, China

Location

Research Site

Suqian, China

Location

Research Site

Tai’an, China

Location

Research Site

Wuhan, China

Location

Research Site

Xuzhou, China

Location

Research Site

Zhengzhou, China

Location

Related Publications (4)

  • Li J, Li X, Wang Q, Hu S, Wang Y, Masoudi FA, Spertus JA, Krumholz HM, Jiang L; China PEACE Collaborative Group. ST-segment elevation myocardial infarction in China from 2001 to 2011 (the China PEACE-Retrospective Acute Myocardial Infarction Study): a retrospective analysis of hospital data. Lancet. 2015 Jan 31;385(9966):441-51. doi: 10.1016/S0140-6736(14)60921-1. Epub 2014 Jun 23.

    PMID: 24969506BACKGROUND

  • Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA; PLATO Investigators; Freij A, Thorsen M. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009 Sep 10;361(11):1045-57. doi: 10.1056/NEJMoa0904327. Epub 2009 Aug 30.

    PMID: 19717846BACKGROUND

  • Task Force on the management of ST-segment elevation acute myocardial infarction of the European Society of Cardiology (ESC); Steg PG, James SK, Atar D, Badano LP, Blomstrom-Lundqvist C, Borger MA, Di Mario C, Dickstein K, Ducrocq G, Fernandez-Aviles F, Gershlick AH, Giannuzzi P, Halvorsen S, Huber K, Juni P, Kastrati A, Knuuti J, Lenzen MJ, Mahaffey KW, Valgimigli M, van 't Hof A, Widimsky P, Zahger D. ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation. Eur Heart J. 2012 Oct;33(20):2569-619. doi: 10.1093/eurheartj/ehs215. Epub 2012 Aug 24. No abstract available.

    PMID: 22922416BACKGROUND

  • Du X, Zheng Y, Yang P, Ma S, Yu Z, Su X, Ge J, Leonsson-Zachrisson M, Wang X, Sun J, Bai L, Ma CS; YINGLONG study investigators. YINGLONG: A Multicenter, Prospective, Non-Interventional Study Evaluating the Safety and Tolerability of Ticagrelor in Chinese Patients with Acute Coronary Syndrome. Adv Ther. 2019 Jul;36(7):1595-1605. doi: 10.1007/s12325-019-00972-z. Epub 2019 May 22.

    PMID: 31119693DERIVED

Related Links

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Changsheng Ma

    Beijing Anzhen Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2015

First Posted

April 30, 2015

Study Start

May 28, 2015

Primary Completion

March 29, 2017

Study Completion

March 29, 2017

Last Updated

March 14, 2018

Record last verified: 2018-03

Locations

CN(15)