Clinical trial NCT02305680: Long-term Follow-up of antithrombotIc Management Patterns in Acute Coronary Syndrome Patients in Asia-China Extension
Official title: EPICOR Asia-China Extension. Long-term Follow-up of antithrombotIc Management Patterns in Acute Coronary Syndrome Patients in Asia-China Extension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndromes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2014-12-03
Enrollment: 2334
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a history of acute coronary syndromes in China

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Long-term antithrombotic management patterns in a real-life setting by assessing the medication and treatment prescribed by physicians
timeFrame: From 2 years after the acute coronary syndrome index event, assessed up to 5 years
Secondary outcomes:
measure: Clinical outcomes by record the number and type of cardiovascular and non-cardiovascular events
timeFrame: From 2 years after the acute coronary syndrome index event, assessed up to 5 years
measure: Health care resource consumption and related costs by assessing the detail hospitalization and outpatient cost.
timeFrame: From 2 years after the acute coronary syndrome index event, assessed up to 5 years
measure: Quality of life by assessing EQ-5D questionnaire.
timeFrame: 2 years,2.5years,3years,3.5years,4years,4.5years,5years after the acute coronary syndrome index event
Other outcomes:
Locations:
city: Baoding
country: China
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Changzhi
country: China
facility: Research Site
city: Chongqing
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Guiyang
country: China
facility: Research Site
city: Haerbin
country: China
facility: Research Site
city: Hangzhou
country: China
facility: Research Site
city: Hebei
country: China
facility: Research Site
city: Jilin
country: China
facility: Research Site
city: Jinan
country: China
facility: Research Site
city: Jinzhong
country: China
facility: Research Site
city: Kunming
country: China
facility: Research Site
city: Lanzhou
country: China
facility: Research Site
city: Nanjing
country: China
facility: Research Site
city: Nanning
country: China
facility: Research Site
city: Peking
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shenyang
country: China
facility: Research Site
city: Shenzhen
country: China
facility: Research Site
city: Shihezi
country: China
facility: Research Site
city: Taiyuan
country: China
facility: Research Site
city: Tangshan
country: China
facility: Research Site
city: Tianjin
country: China
facility: Research Site
city: Wuhan
country: China
facility: Research Site
city: Wulumuqi
country: China
facility: Research Site
city: Wuxi
country: China
facility: Research Site
city: Xian
country: China
facility: Research Site
city: Xining
country: China
facility: Research Site
city: Xuzhou
country: China
facility: Research Site
city: Yinchuan
country: China
facility: Research Site
city: Yulin
country: China
facility: Research Site
city: Zhengzhou
country: China
facility: Research Site
city: Zhenjiang
country: China
facility: Research Site
Study officials:
affiliation: Peking University First Hospital
name: Yong Huo, Doctor
role: PRINCIPAL_INVESTIGATOR
References: