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 Products containing cinepazide have been withdrawn in 1990s by the manufacturers because of lacking of demonstrated efficacy and the risk of agranulocytosis in some European countries, such as France, Spain,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
π¨π³Wuhan, Hebei, China
China Rehabilitation Research Center
π¨π³Beijing, Beijing, China
Dongfang Hospital,the second clinical medical College of Beijing University of Chinese Medicine(BUCM)
π¨π³Beijing, Beijing, China
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
π¨π³Beijing, Beijing, China
Beijing Chuiyangliu Hospital(Beijing Minimally Invasive Hospital)
π¨π³Beijing, Beijing, China
Hua Xin Hospital; First Hospital of Tsing Hua University
π¨π³Beijing, Beijing, China
Xuanwu Hospital Affiliated to Capital Medical University
π¨π³Beijing, Beijing, China
Beijing Shijitan Hospital,the 9th Clinical Medical College of Peking university
π¨π³Beijing, Beijing, China
Peking University Third Hospital
π¨π³Beijing, Beijing, China
Gansu Provincial Hospital
π¨π³Lanzhou, Gansu, China
The First Affiliated Hospital of Lanzhou University
π¨π³Lanzhou, Gansu, China
Central People's Hospital of Zhanjiang
π¨π³Ganjiang, Guangdong, China
The People's Hospital of Gaozhou
π¨π³Gaozhou, Guangdong, China
GuangZhou First People's Hospital
π¨π³Guangzhou, Guangdong, China
Panyu Hospital of Chinese Medicine
π¨π³Guangzhou, Guangdong, China
Sun Yat-Sen Memorial Hospital Sun Yat-Sen University
π¨π³Guangzhou, Guangdong, China
The Second Affiliated Hospital of Guangzhou Medical University
π¨π³Guangzhou, Guangdong, China
ZhuJiang Hospital of Southern Medical University
π¨π³Guangzhou, Guangdong, China
Shantou Central Hospital Affiliated Shantou Hospital of Sun Yan-Sen University
π¨π³Shantou, Guangdong, China
The Second Affiliated Hospital of Shantou University Medical College
π¨π³Shantou, Guangdong, China
Hospital of Traditional Chinese Medicine of Zhongshan
π¨π³Zhongshan, Guangdong, China
People's Hospital of Dongxihu District
π¨π³Wuhan, Hebei, China
People's Hospital of Heilongjiang Province
π¨π³Harbin, Heilongjiang, China
The 2nd Affiliated Hospital of Harbin Medical University
π¨π³Harbin, Heilongjiang, China
The First Affiliated Hospital of Harbin Medical University
π¨π³Harbin, Heilongjiang, China
The First Affiliated Hospital of Heilongjiang University Of Chinese Medicine
π¨π³Harbin, Heilongjiang, China
The first hospital of Harbin City
π¨π³Harbin, Heilongjiang, China
The Second Affiliated of Heilongjiang University of Chinese Medicine
π¨π³Harbin, Heilongjiang, China
Renmin Hospital of Wuhan
π¨π³Wuhan, Hubei, China
Tongji Hospital
π¨π³Wuhan, Hubei, China
Hunan Provincial People's Hospital
π¨π³Changsha, Hunan, China
Wuhan Union Hospital
π¨π³Wuhan, Hubei, China
The First Hospital of Changsha
π¨π³Changsha, Hunan, China
The Second Xiangya Hospital of Central South University
π¨π³Changsha, Hunan, China
The Third Hospital of Changsha
π¨π³Changsha, Hunan, China
The Third Xiangya Hospital of Central South University
π¨π³Changsha, Hunan, China
Xiangya Hospital Central-South University
π¨π³Changsha, Hunan, China
Jiangxi Provincial People's Hospital
π¨π³Nanchang, Jiangxi, China
The First Affiliated Hospital of Nanchang University
π¨π³Nanchang, Jiangxi, China
The Second Affiliated Hospital of Nanchang University
π¨π³Nanchang, Jiangxi, China
The Third Affiliated Hospital of Nanchang University
π¨π³Nanchang, Jiangxi, China
The Third Hospital of Nanchang
π¨π³Nanchang, Jiangxi, China
Affiliated Hospital of Beihua University
π¨π³Jilin, Jilin, China
Shenyang First People's Hospital
π¨π³Shenyang, Liaoning, China
Shenzhou Hospital to Shenyang Medical College
π¨π³Shenyang, Liaoning, China
The First Affiliated Hospital of China Medical University
π¨π³Shenyang, Liaoning, China
The people's Liberation Army 202nd hospital
π¨π³Shenyang, Liaoning, China
The four six three hospital of people's Liberation Army
π¨π³Shenyang, Liaoning, China
The Fourth Affiliated Hospital of China Medical University
π¨π³Shenyang, Liaoning, China
Ankang City Central Hospital
π¨π³Ankang, Shaanxi, China
San Er Ling Yi Hospital
π¨π³Hanzhong, Shaanxi, China
First Affiliated Hospital of Medical College of Xian Jiaotong University
π¨π³Xi'an, Shaanxi, China
Tangdu Hospital
π¨π³Xi'an, Shaanxi, China
The Central Hospital of Xi'an
π¨π³Xi'an, Shaanxi, China
Xijing Hospital
π¨π³Xi'an, Shaanxi, China
Binzhou People's Hospital
π¨π³Binzhou, Shandong, China
The Fourth Affiliated Hospital of Harbin Medical University
π¨π³Harbin, Heilongjiang, China
Jilin Province People's Hospital
π¨π³Changchun, Jilin, China
General Hospital of Shenyang military area command of Chinese PLA
π¨π³Shenyang, Liaoning, China
Qilu Hospital of Shandong University
π¨π³Jinan, Shandong, China
Fu Xing Hospital,Capital Medical University
π¨π³Beijing, Beijing, China