Overview

This trial is active, not recruiting.

Condition acute coronary syndrome (acs)
Sponsor AstraZeneca
Start date May 2015
End date July 2017
Trial size 1000 participants
Trial identifier NCT02430493, D5130R00026

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Chinese subjects aged over 18, diagnosed as ACS and treated with ticagrelor at least one tablet

Primary Outcomes

Measure
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

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 130 years old.

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

Additional Information

Official title A Multi-Centre, Prospective Cohort, Non-Interventional Study About Evaluation on the Safety of Ticagrelor Among Chinese ACS Patients
Principal investigator Changsheng Ma
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.