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NCT02305680 Clinical Trial

Long-term Follow-up of antithrombotIc Management Patterns in Acute Coronary Syndrome Patients in Asia-China Extension

Acute Coronary Syndromes Clinical Trial

— EPICOR  

Official title:
EPICOR Asia-China Extension. Long-term Follow-up of antithrombotIc Management Patterns in Acute Coronary Syndrome Patients in Asia-China Extension

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02305680
Other study ID # D1843R00049
Secondary ID NIS-CCN-XXX-2014
Status Completed
Phase
First received
Last updated
Start date December 17, 2014
Est. completion date April 5, 2017

Study information
Verified date September 2018
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is to describe the long-term antithrombotic management patterns in a real-life setting for patients hospitalized with an acute coronary syndrome in China.

Description:

This study is to describe the long-term (3 to 5 years after the acute coronary syndrome index event) antithrombotic management patterns in a real-life setting for patients hospitalized with an acute coronary syndrome (i.e. ST-segment Elevation Myocardial Infarction, Non-ST-segment Elevation Myocardial Infarction, Unstable Angina) in China.

Recruitment information / eligibility
Status Completed
Enrollment 2334
Est. completion date April 5, 2017
Est. primary completion date April 5, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

1. Written informed consent has been provided.

2. Contact Order Form has been provided

3. Aged 18 years or older.

4. Enrolled in EPICOR Asia study and completed the 2 year follow-up.

Exclusion Criteria:

1. Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient (e.g. tourist, non-native speaker or does not understand the local language, psychiatric disturbances, alcohol or drug abuse).

2. Already included in the EPICOR Asia-China Extension observational study.

3. Presence of serious/severe co-morbidities in the opinion of the investigator which may limit short term (i.e. 6 month) life expectancy.

4. Current participation in an interventional clinical trial.

5. Patients receiving ticagrelor beyond 12 months and other off label use.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Research Site Baoding
China Research Site Beijing
China Research Site Changzhi
China Research Site Chongqing
China Research Site Guangzhou
China Research Site Guiyang
China Research Site Haerbin
China Research Site Hangzhou
China Research Site Hebei
China Research Site Jilin
China Research Site Jinan
China Research Site Jinzhong
China Research Site Kunming
China Research Site Lanzhou
China Research Site Nanjing
China Research Site Nanning
China Research Site Peking
China Research Site Shanghai
China Research Site Shenyang
China Research Site Shenzhen
China Research Site Shihezi
China Research Site Taiyuan
China Research Site Tangshan
China Research Site Tianjin
China Research Site Wuhan
China Research Site Wulumuqi
China Research Site Wuxi
China Research Site Xian
China Research Site Xining
China Research Site Xuzhou
China Research Site Yinchuan
China Research Site Yulin
China Research Site Zhengzhou
China Research Site Zhenjiang

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Long-term antithrombotic management patterns in a real-life setting by assessing the medication and treatment prescribed by physicians From 2 years after the acute coronary syndrome index event, assessed up to 5 years
Secondary Clinical outcomes by record the number and type of cardiovascular and non-cardiovascular events From 2 years after the acute coronary syndrome index event, assessed up to 5 years
Secondary Health care resource consumption and related costs by assessing the detail hospitalization and outpatient cost. From 2 years after the acute coronary syndrome index event, assessed up to 5 years
Secondary Quality of life by assessing EQ-5D questionnaire. 2 years,2.5years,3years,3.5years,4years,4.5years,5years after the acute coronary syndrome index event
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