Post-Marketing Surveillance of the Cinepazide Maleate Injection: a Real World Study
- Conditions
- Adverse Drug ReactionCinepazideStroke
- Registration Number
- NCT01946919
- Lead Sponsor
- Peking University Third Hospital
- Brief Summary
Cinepazide Maleate Injection is widely used in cerebrovascular disease in china. The safety of the cinepazide, especially the blood system, has not been fully evaluated in Chinese population. In order to improve the rational use of cinepazide, the investigators observe its clinical use in the real world in China, evaluate its safety and clinical benefit in a large Chinese population.
- Detailed Description
Cinepazide was firstly approved in France in 1974, and the formulations are injection and tablet. Products containing cinepazide have been withdrawn in 1990s by the manufacturers because of lacking of demonstrated efficacy and the risk of agranulocytosis in some European countries, such as France, Spain, Italy. In some Aisa countries, it has not been re-registered in Japan in 2000s, and the injection is still used in China and Korea. In china, Cinepazide Maleate Injection was approved by China Food and Drug Administration(CFDA) in 2002, and widely used in cerebrovascular disease. The safety of the Cinepazide, especially the adverse drug reactions in the blood system, has not benn fully evaluated in Chinese population. In this study, clinical pharmacists in selected hospitals will record the clinical use and the adverse drug reactions/ adverse drug events of this injection. This real world study for Cinepazide Maleate Injection with 18000 patients will be conducted from Sep. 2012 to June. 2014.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18260
- Inpatient using the cinepazide in the department of neurology
- none
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of adverse drug reaction of cinepazide in department of neurology 1.5 years
- Secondary Outcome Measures
Name Time Method Types of the adverse drug reaction of cinepazide. 1.5 years The types of the adverse drug reaction of cinepazide including Nausea, vomiting, itching and etc.
Outcomes of the patients who experienced an adverse drug reaction of cinepazide. 1.5 years Outcomes including cure, improved, null, or death.
The treatment when patients experienced an adverse drug reaction of cinepazide. 1.5 years Treatments including oxygen, steroids, and etc. According to severity of the adverse drug reactions, we will analyse the features the treatments, such as types and numbers.
The predictors of the adverse drug reaction of cinepazide 1.5 years We will analyse whether some factors, such as age, gender, medical history and etc, would be the predictors of the adverse drug reaction of cinepazide.
Trial Locations
- Locations (61)
Shenlong Hospital
🇨🇳Wuhan, Hebei, China
China Rehabilitation Research Center
🇨🇳Beijing, Beijing, China
Dongfang Hospital,the second clinical medical College of Beijing University of Chinese Medicine(BUCM)
🇨🇳Beijing, Beijing, China
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
🇨🇳Beijing, Beijing, China
Beijing Chuiyangliu Hospital(Beijing Minimally Invasive Hospital)
🇨🇳Beijing, Beijing, China
Hua Xin Hospital; First Hospital of Tsing Hua University
🇨🇳Beijing, Beijing, China
Xuanwu Hospital Affiliated to Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Shijitan Hospital,the 9th Clinical Medical College of Peking university
🇨🇳Beijing, Beijing, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
Gansu Provincial Hospital
🇨🇳Lanzhou, Gansu, China
The First Affiliated Hospital of Lanzhou University
🇨🇳Lanzhou, Gansu, China
Central People's Hospital of Zhanjiang
🇨🇳Ganjiang, Guangdong, China
The People's Hospital of Gaozhou
🇨🇳Gaozhou, Guangdong, China
GuangZhou First People's Hospital
🇨🇳Guangzhou, Guangdong, China
Panyu Hospital of Chinese Medicine
🇨🇳Guangzhou, Guangdong, China
Sun Yat-Sen Memorial Hospital Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China
The Second Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
ZhuJiang Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
Shantou Central Hospital Affiliated Shantou Hospital of Sun Yan-Sen University
🇨🇳Shantou, Guangdong, China
The Second Affiliated Hospital of Shantou University Medical College
🇨🇳Shantou, Guangdong, China
Hospital of Traditional Chinese Medicine of Zhongshan
🇨🇳Zhongshan, Guangdong, China
People's Hospital of Dongxihu District
🇨🇳Wuhan, Hebei, China
People's Hospital of Heilongjiang Province
🇨🇳Harbin, Heilongjiang, China
The 2nd Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
The First Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
The First Affiliated Hospital of Heilongjiang University Of Chinese Medicine
🇨🇳Harbin, Heilongjiang, China
The first hospital of Harbin City
🇨🇳Harbin, Heilongjiang, China
The Second Affiliated of Heilongjiang University of Chinese Medicine
🇨🇳Harbin, Heilongjiang, China
Renmin Hospital of Wuhan
🇨🇳Wuhan, Hubei, China
Tongji Hospital
🇨🇳Wuhan, Hubei, China
Hunan Provincial People's Hospital
🇨🇳Changsha, Hunan, China
Wuhan Union Hospital
🇨🇳Wuhan, Hubei, China
The First Hospital of Changsha
🇨🇳Changsha, Hunan, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
The Third Hospital of Changsha
🇨🇳Changsha, Hunan, China
The Third Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Xiangya Hospital Central-South University
🇨🇳Changsha, Hunan, China
Jiangxi Provincial People's Hospital
🇨🇳Nanchang, Jiangxi, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
The Second Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
The Third Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
The Third Hospital of Nanchang
🇨🇳Nanchang, Jiangxi, China
Affiliated Hospital of Beihua University
🇨🇳Jilin, Jilin, China
Shenyang First People's Hospital
🇨🇳Shenyang, Liaoning, China
Shenzhou Hospital to Shenyang Medical College
🇨🇳Shenyang, Liaoning, China
The First Affiliated Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
The people's Liberation Army 202nd hospital
🇨🇳Shenyang, Liaoning, China
The four six three hospital of people's Liberation Army
🇨🇳Shenyang, Liaoning, China
The Fourth Affiliated Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Ankang City Central Hospital
🇨🇳Ankang, Shaanxi, China
San Er Ling Yi Hospital
🇨🇳Hanzhong, Shaanxi, China
First Affiliated Hospital of Medical College of Xian Jiaotong University
🇨🇳Xi'an, Shaanxi, China
Tangdu Hospital
🇨🇳Xi'an, Shaanxi, China
The Central Hospital of Xi'an
🇨🇳Xi'an, Shaanxi, China
Xijing Hospital
🇨🇳Xi'an, Shaanxi, China
Binzhou People's Hospital
🇨🇳Binzhou, Shandong, China
The Fourth Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
Jilin Province People's Hospital
🇨🇳Changchun, Jilin, China
General Hospital of Shenyang military area command of Chinese PLA
🇨🇳Shenyang, Liaoning, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
Fu Xing Hospital,Capital Medical University
🇨🇳Beijing, Beijing, China