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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01361386
Other study ID # NIS-CAP-XXX-2011/1
Secondary ID
Status Completed
Phase N/A
First received May 23, 2011
Last updated June 13, 2014
Start date June 2011
Est. completion date May 2014

Study information

Verified date June 2014
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Vietnam: Ministry of Health
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 13011
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
China Research Site Baoding Hebei
China Research Site Beijing Beijing
China Research Site Changchun Jilin
China Research Site Changsha Hunan
China Research Site Changzhi Shanxi
China Research Site Chengdu Sichuan
China Research Site Chongqing Chongqing
China Research Site Daqing Heilongjiang
China Research Site Foshan Guangdong
China Research Site Fuzhou Fujian
China Research Site Guangzhou Guangdong
China Research Site Guiyang Guizhou
China Research Site Hangzhou Zhejiang
China Research Site Harbin Heilongjiang
China Research Site Hefei Anhui
China Research Site HongKong
China Research Site Jinan Shandong
China Research Site Jinzhong Shanxi
China Research Site Jinzhou Liaoning
China Research Site Kunming Yunnan
China Research Site Lanzhou Gansu
China Research Site Nanjing Jiangsu
China Research Site Nanning Guangxi
China Research Site Ningxia
China Research Site Qingdao
China Research Site Shanghai Shanghai
China Research Site Shenyang Liaoning
China Research Site Shenzhen Guangdong
China Research Site Shihezi Xinjiang
China Research Site Shijiazhuang Hebei
China Research Site Shiyan Hubei
China Research Site Taiyuan Shanxi
China Research Site Tangshan Hebei
China Research Site Tianjin Tianjin
China Research Site Urumuqi Xinjiang
China Research Site Wuhan Hubei
China Research Site Wuhu Anhui
China Research Site Wuxi Jiangsu
China Research Site Xi'an Shaanxi
China Research Site Xining Qinghai
China Research Site Xuzhou Jiangsu
China Research Site Yingkou Liaoning
China Research Site Yulin Guangxi
China Research Site Zhengzhou Henan
China Research Site Zhenjiang Jiangsu
India Research Site Ahmedabad Gujarat
India Research Site Ajmer Rajasthan
India Research Site Aurangabad Maharashtra
India Research Site Bangalore Karnataka
India Research Site Baroda Gujarat
India Research Site Bhopal Madhya Pradesh
India Research Site Bilaspur Madhya Pradesh
India Research Site Chennai Tamil Nadu
India Research Site Coimbatore Tamil Nadu
India Research Site Delhi
India Research Site Gurgaon Haryana
India Research Site Guwahati Assam
India Research Site Hyderabad Andhra Pradesh
India Research Site Jaipur Rajasthan
India Research Site Kochi Kerala
India Research Site Kolkata West Bengal
India Research Site Lucknow Uttar Pradesh
India Research Site Ludhiana Punjab
India Research Site Madurai Tamil Nadu
India Research Site Manipal Karnataka
India Research Site Mohali Punjab
India Research Site Mumbai Maharashtra
India Research Site Nagpur Maharashtra
India Research Site Pune Maharashtra
India Research Site Surat Gujarat
India Research Site Trivandrum Kerala
Korea, Republic of Research Site Bucheon Gyeonggi-do
Korea, Republic of Research Site Busan
Korea, Republic of Research Site Cheonan Chungcheongnam-do
Korea, Republic of Research Site Chuncheon
Korea, Republic of Research Site Deagu
Korea, Republic of Research Site Goyang-si Gyeonggi-do
Korea, Republic of Research Site Gwangju
Korea, Republic of Research Site IKsan Jeollabuk-do
Korea, Republic of Research Site Jeju
Korea, Republic of Research Site Pusan
Korea, Republic of Research Site Seoul
Korea, Republic of Research Site Suwon Gyeonggi-do
Korea, Republic of Research Site Yangsan Gyeongsangnamdo
Malaysia Research Site Penang
Malaysia Research Site Sarawak Kuching
Singapore Research Site Singapore
Thailand Research Site Bangkoknoi Bangkok
Thailand Research Site Huaykwang Bangkok
Thailand Research Site Klongluang Pathumthani
Thailand Research Site Muang Phitsanulok
Thailand Research Site Muang Songkla
Thailand Research Site Muang Suphanburi
Thailand Research Site Muang Surat Thani
Thailand Research Site Muang Udonthani
Thailand Research Site Muang Chanthaburi
Thailand Research Site Muang Chiangmai
Thailand Research Site Muang Chiangrai
Thailand Research Site Muang Chonburi
Thailand Research Site Muang Khonkaen
Thailand Research Site Muang Lampang
Thailand Research Site Muang Nakornratchaseema
Thailand Research Site Muang Nan
Thailand Research Site PathumWan Bangkok
Thailand Research Site Payathai Bangkok
Thailand Research Site Rachathevi Bangkok
Thailand Research Site Saimai Bangkok
Vietnam Research Site Ho Chi Minh City
Vietnam Research Site Hue

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

China,  India,  Korea, Republic of,  Malaysia,  Singapore,  Thailand,  Vietnam, 

Outcome

Type Measure Description Time frame Safety issue
Primary short- and long-term medication and treatment prescribed by physicians in real-life setting up to 3 years No
Secondary clinical outcome (Cardiovascular events) up to 3 years No
Secondary cost of hospitalization up to 3 years No
Secondary quality of life (EQ-5D questionnaire) up to 3 years No
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