Clinical trial NCT01361386: Long-tErm Follow-uP of antithrombotIc Management Patterns In Acute CORonary Syndrome Patients in Asia
Official title: Long-Term Follow-up of Antithrombotic Management Patterns in Acute Coronary Syndrome Patients in Asia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Keywords: Long-term follow up
Antithrombotic management patterns
Acute Coronary Syndrome
Asia
quality of life
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-05-26
Enrollment: 13011
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Asian patients hospitalized for ACS within 48 hours of symptom onset and who have a final diagnosis of unstable angina (UA), STEMI or non-ST-segment elevation myocardial infarction (NSTEMI).

Brief summary: The purpose of this study is to describe the short-and long-tern (i.e. up to 2 years following the index event) AMPs in patients hospitalized for an acute coronary syndrome (i.e. STEMI or NSTE-ACS), and to document clinical outcomes, economic aspects and impact on quality of life of these AMPs in a 'real-life' setting.


Eligibility criteria: Inclusion Criteria:

* Written informed consent has been provided.
* Diagnosis of STEMI, NSTEMI or UA
* Hospitalization for the first time within 48 hours of onset of symptoms.

Exclusion Criteria:

* UA, STEMI, NSTEMI precipitated by or as a complication of surgery, trauma, or GI bleeding or post-PCI UA, STEMI and NSTEMI occurring in patients already hospitalized for other reasons.
* Current participation in a randomised interventional clinical trial.

Primary outcomes:
measure: short- and long-term medication and treatment prescribed by physicians in real-life setting
timeFrame: up to 3 years
Secondary outcomes:
measure: clinical outcome (Cardiovascular events)
timeFrame: up to 3 years
measure: cost of hospitalization
timeFrame: up to 3 years
measure: quality of life (EQ-5D questionnaire)
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Hefei
country: China
facility: Research Site
state: Anhui
city: Wuhu
country: China
facility: Research Site
state: Anhui
city: Beijing
country: China
facility: Research Site
state: Beijing
city: Chongqing
country: China
facility: Research Site
state: Chongqing
city: Fuzhou
country: China
facility: Research Site
state: Fujian
city: Lanzhou
country: China
facility: Research Site
state: Gansu
city: Foshan
country: China
facility: Research Site
state: Guangdong
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Shenzhen
country: China
facility: Research Site
state: Guangdong
city: Nanning
country: China
facility: Research Site
state: Guangxi
city: Yulin
country: China
facility: Research Site
state: Guangxi
city: Guiyang
country: China
facility: Research Site
state: Guizhou
city: Baoding
country: China
facility: Research Site
state: Hebei
city: Shijiazhuang
country: China
facility: Research Site
state: Hebei
city: Tangshan
country: China
facility: Research Site
state: Hebei
city: Daqing
country: China
facility: Research Site
state: Heilongjiang
city: Harbin
country: China
facility: Research Site
state: Heilongjiang
city: Zhengzhou
country: China
facility: Research Site
state: Henan
city: Shiyan
country: China
facility: Research Site
state: Hubei
city: Wuhan
country: China
facility: Research Site
state: Hubei
city: Changsha
country: China
facility: Research Site
state: Hunan
city: Nanjing
country: China
facility: Research Site
state: Jiangsu
city: Wuxi
country: China
facility: Research Site
state: Jiangsu
city: Xuzhou
country: China
facility: Research Site
state: Jiangsu
city: Zhenjiang
country: China
facility: Research Site
state: Jiangsu
city: Changchun
country: China
facility: Research Site
state: Jilin
city: Jinzhou
country: China
facility: Research Site
state: Liaoning
city: Shenyang
country: China
facility: Research Site
state: Liaoning
city: Yingkou
country: China
facility: Research Site
state: Liaoning
city: Xining
country: China
facility: Research Site
state: Qinghai
city: Xi'an
country: China
facility: Research Site
state: Shaanxi
city: Jinan
country: China
facility: Research Site
state: Shandong
city: Shanghai
country: China
facility: Research Site
state: Shanghai
city: Changzhi
country: China
facility: Research Site
state: Shanxi
city: Jinzhong
country: China
facility: Research Site
state: Shanxi
city: Taiyuan
country: China
facility: Research Site
state: Shanxi
city: Chengdu
country: China
facility: Research Site
state: Sichuan
city: Tianjin
country: China
facility: Research Site
state: Tianjin
city: Shihezi
country: China
facility: Research Site
state: Xinjiang
city: Urumuqi
country: China
facility: Research Site
state: Xinjiang
city: Kunming
country: China
facility: Research Site
state: Yunnan
city: Hangzhou
country: China
facility: Research Site
state: Zhejiang
city: HongKong
country: China
facility: Research Site
city: Ningxia
country: China
facility: Research Site
city: Qingdao
country: China
facility: Research Site
city: Hyderabad
country: India
facility: Research Site
state: Andhra Pradesh
city: Guwahati
country: India
facility: Research Site
state: Assam
city: Ahmedabad
country: India
facility: Research Site
state: Gujarat
city: Baroda
country: India
facility: Research Site
state: Gujarat
city: Surat
country: India
facility: Research Site
state: Gujarat
city: Gurgaon
country: India
facility: Research Site
state: Haryana
city: Bangalore
country: India
facility: Research Site
state: Karnataka
city: Manipal
country: India
facility: Research Site
state: Karnataka
city: Kochi
country: India
facility: Research Site
state: Kerala
city: Trivandrum
country: India
facility: Research Site
state: Kerala
city: Bhopal
country: India
facility: Research Site
state: Madhya Pradesh
city: Bilaspur
country: India
facility: Research Site
state: Madhya Pradesh
city: Aurangabad
country: India
facility: Research Site
state: Maharashtra
city: Mumbai
country: India
facility: Research Site
state: Maharashtra
city: Nagpur
country: India
facility: Research Site
state: Maharashtra
city: Pune
country: India
facility: Research Site
state: Maharashtra
city: Ludhiana
country: India
facility: Research Site
state: Punjab
city: Mohali
country: India
facility: Research Site
state: Punjab
city: Ajmer
country: India
facility: Research Site
state: Rajasthan
city: Jaipur
country: India
facility: Research Site
state: Rajasthan
city: Chennai
country: India
facility: Research Site
state: Tamil Nadu
city: Coimbatore
country: India
facility: Research Site
state: Tamil Nadu
city: Madurai
country: India
facility: Research Site
state: Tamil Nadu
city: Lucknow
country: India
facility: Research Site
state: Uttar Pradesh
city: Kolkata
country: India
facility: Research Site
state: West Bengal
city: Delhi
country: India
facility: Research Site
city: Cheonan
country: Korea, Republic of
facility: Research Site
state: Chungcheongnam-do
city: Bucheon
country: Korea, Republic of
facility: Research Site
state: Gyeonggi-do
city: Goyang-si
country: Korea, Republic of
facility: Research Site
state: Gyeonggi-do
city: Suwon
country: Korea, Republic of
facility: Research Site
state: Gyeonggi-do
city: Yangsan
country: Korea, Republic of
facility: Research Site
state: Gyeongsangnamdo
city: IKsan
country: Korea, Republic of
facility: Research Site
state: Jeollabuk-do
city: Busan
country: Korea, Republic of
facility: Research Site
city: Chuncheon
country: Korea, Republic of
facility: Research Site
city: Deagu
country: Korea, Republic of
facility: Research Site
city: Gwangju
country: Korea, Republic of
facility: Research Site
city: Jeju
country: Korea, Republic of
facility: Research Site
city: Pusan
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Sarawak
country: Malaysia
facility: Research Site
state: Kuching
city: Penang
country: Malaysia
facility: Research Site
city: Singapore
country: Singapore
facility: Research Site
city: Bangkoknoi
country: Thailand
facility: Research Site
state: Bangkok
city: Huaykwang
country: Thailand
facility: Research Site
state: Bangkok
city: PathumWan
country: Thailand
facility: Research Site
state: Bangkok
city: Payathai
country: Thailand
facility: Research Site
state: Bangkok
city: Rachathevi
country: Thailand
facility: Research Site
state: Bangkok
city: Saimai
country: Thailand
facility: Research Site
state: Bangkok
city: Muang
country: Thailand
facility: Research Site
state: Chanthaburi
city: Muang
country: Thailand
facility: Research Site
state: Chiangmai
city: Muang
country: Thailand
facility: Research Site
state: Chiangrai
city: Muang
country: Thailand
facility: Research Site
state: Chonburi
city: Muang
country: Thailand
facility: Research Site
state: Khonkaen
city: Muang
country: Thailand
facility: Research Site
state: Lampang
city: Muang
country: Thailand
facility: Research Site
state: Nakornratchaseema
city: Muang
country: Thailand
facility: Research Site
state: Nan
city: Klongluang
country: Thailand
facility: Research Site
state: Pathumthani
city: Muang
country: Thailand
facility: Research Site
state: Phitsanulok
city: Muang
country: Thailand
facility: Research Site
state: Songkla
city: Muang
country: Thailand
facility: Research Site
state: Suphanburi
city: Muang
country: Thailand
facility: Research Site
state: Surat Thani
city: Muang
country: Thailand
facility: Research Site
state: Udonthani
city: Ho Chi Minh City
country: Vietnam
facility: Research Site
city: Hue
country: Vietnam
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Guy Yeoman
role: STUDY_DIRECTOR
affiliation: Peking University 1st Hospital
name: Prof. Huo Yong
role: STUDY_CHAIR
affiliation: AstraZeneca
name: Jayanti Visvanathan
role: STUDY_CHAIR
References:
citation: Huo Y, Van de Werf F, Han Y, Rossello X, Pocock SJ, Chin CT, Lee SW, Li Y, Jiang J, Vega AM, Medina J, Bueno H. Long-Term Antithrombotic Therapy and Clinical Outcomes in Patients with Acute Coronary Syndrome and Renal Impairment: Insights from EPICOR and EPICOR Asia. Am J Cardiovasc Drugs. 2021 Jul;21(4):471-482. doi: 10.1007/s40256-020-00447-5. Epub 2021 Feb 4.
citation: Guan S, Xu X, Li Y, Li J, Guan M, Wang X, Jing Q, Huo Y, Han Y. Impact of Diabetes Mellitus on Antithrombotic Management Patterns and Long-Term Clinical Outcomes in Patients With Acute Coronary Syndrome: Insights From the EPICOR Asia Study. J Am Heart Assoc. 2020 Nov 17;9(22):e013476. doi: 10.1161/JAHA.119.013476. Epub 2020 Nov 7.
citation: Zhang S, Wang W, Sawhney JPS, Krittayaphong R, Kim HS, Nhan VT, Lee SW, Ong TK, Chin CT, Pocock SJ, Huo Y, Qian J, Ge J. Antithrombotic management and long-term outcomes following percutaneous coronary intervention for acute coronary syndrome in Asia. Int J Cardiol. 2020 Jul 1;310:16-22. doi: 10.1016/j.ijcard.2020.01.008. Epub 2020 Mar 17.
citation: Jan S, Lee SW, Sawhney JPS, Ong TK, Chin CT, Kim HS, Krittayaphong R, Nhan VT, Pocock SJ, Vega AM, Hayashi N, Huo Y. Predictors of high-cost hospitalization in the treatment of acute coronary syndrome in Asia: findings from EPICOR Asia. BMC Cardiovasc Disord. 2018 Jul 4;18(1):139. doi: 10.1186/s12872-018-0859-4.