Clinical trial NCT01946919: Post-Marketing Surveillance of the Cinepazide Maleate Injection: a Real World Study
Official title: Post-Marketing Surveillance of the Cinepazide Maleate Injection: a Real World Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adverse Drug Reaction
Cinepazide
Stroke
Keywords: Cinepazide
Adverse Drug Reaction
Safety
Real World Study
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Sihuan Pharmaceutical Co. Ltd.
name: Beijing Shijitan Hospital,the 9th Clinical Medical College of Peking university
name: China Rehabilitation Research Center
name: Hua Xin Hospital First Hospital of Tsing Hua University
name: Fu Xing Hospital, Capital Medical University
name: Beijing Chuiyangliu Hospital(Beijing Minimally Invasive Hospital)
name: Dongfang Hospital Beijing University of Chinese Medicine
name: Dongzhimen Hospital, Beijing
name: Xuanwu Hospital, Beijing
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Southern Medical University, China
name: Guangzhou First People's Hospital
name: Panyu Hospital of Traditional Chinese Medicine
name: Second Affiliated Hospital of Guangzhou Medical University
name: The People's Hospital of Gaozhou
name: Zhongshan Hospital Of Traditional Chinese Medicine
name: Second Affiliated Hospital of Shantou University Medical College
name: Sun Yat-sen University
name: Central People's Hospital of Zhanjiang
name: Wuhan Union Hospital, China
name: Tongji Hospital
name: Renmin Hospital of Wuhan University
name: People's Hospital of Dongxihu District
name: Shenlong Hospital
name: Xiangya Hospital of Central South University
name: Central South University
name: The Third Xiangya Hospital of Central South University
name: Hunan Provincial People's Hospital
name: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
name: The Third Hospital of Changsha
name: Ankang City Central Hospital
name: San Er Ling Yi Hospital
name: Xijing Hospital
name: Tang-Du Hospital
name: First Affiliated Hospital Xi'an Jiaotong University
name: Gansu Provincial Hospital
name: Xi'an Central Hospital
name: LanZhou University
name: Qilu Hospital of Shandong University
name: Binzhou People's Hospital
name: Jiangxi Provincial People's Hopital
name: The First Affiliated Hospital of Nanchang University
name: Second Affiliated Hospital of Nanchang University
name: The Third Affiliated Hospital of Nanchang University
name: The Third Hospital of Nanchang
name: First Affiliated Hospital of Harbin Medical University
name: First Affiliated Hospital of Heilongjiang Chinese Medicine University
name: People's Hospital of Heilongjiang Province
name: The Second Affiliated Hospital of Harbin Medical University
name: The first hospital of Harbin City
name: The Fourth Affiliated Hospital of Harbin Medical University
name: Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
name: First Hospital of China Medical University
name: People's Liberation Army No.202 Hospital
name: The Fourth Affiliated Hospital of China Medical University
name: General Hospital of Shenyang Military Region
name: The four six three hospital of people's Liberation Army
name: First People's Hospital of Shenyang
name: Jilin Province People's Hospital
name: Beihua University
name: Shenzhou Hospital to Shenyang Medical College
First posted: 2013-09-20
Enrollment: 18260
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatient using the cinepazide in the department of neurology in 61 hospitals in China.

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.

Eligibility criteria: Inclusion Criteria:

* Inpatient using the cinepazide in the department of neurology

Exclusion Criteria:

* none

Primary outcomes:
measure: Incidence of adverse drug reaction of cinepazide in department of neurology
timeFrame: 1.5 years
Secondary outcomes:
measure: Outcomes of the patients who experienced an adverse drug reaction of cinepazide.
timeFrame: 1.5 years
measure: The predictors of the adverse drug reaction of cinepazide
timeFrame: 1.5 years
measure: Types of the adverse drug reaction of cinepazide.
timeFrame: 1.5 years
measure: The treatment when patients experienced an adverse drug reaction of cinepazide.
timeFrame: 1.5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: China Rehabilitation Research Center
state: Beijing
city: Beijing
country: China
facility: Dongfang Hospital,the second clinical medical College of Beijing University of Chinese Medicine(BUCM)
state: Beijing
city: Beijing
country: China
facility: Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
state: Beijing
city: Beijing
country: China
facility: Fu Xing Hospital,Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Chuiyangliu Hospital(Beijing Minimally Invasive Hospital)
state: Beijing
city: Beijing
country: China
facility: Hua Xin Hospital; First Hospital of Tsing Hua University
state: Beijing
city: Beijing
country: China
facility: Xuanwu Hospital Affiliated to Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Shijitan Hospital,the 9th Clinical Medical College of Peking university
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Lanzhou
country: China
facility: Gansu Provincial Hospital
state: Gansu
city: Lanzhou
country: China
facility: The First Affiliated Hospital of Lanzhou University
state: Gansu
city: Ganjiang
country: China
facility: Central People's Hospital of Zhanjiang
state: Guangdong
city: Gaozhou
country: China
facility: The People's Hospital of Gaozhou
state: Guangdong
city: Guangzhou
country: China
facility: GuangZhou First People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Panyu Hospital of Chinese Medicine
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital Sun Yat-Sen University
state: Guangdong
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: ZhuJiang Hospital of Southern Medical University
state: Guangdong
city: Shantou
country: China
facility: Shantou Central Hospital Affiliated Shantou Hospital of Sun Yan-Sen University
state: Guangdong
city: Shantou
country: China
facility: The Second Affiliated Hospital of Shantou University Medical College
state: Guangdong
city: Zhongshan
country: China
facility: Hospital of Traditional Chinese Medicine of Zhongshan
state: Guangdong
city: Wuhan
country: China
facility: People's Hospital of Dongxihu District
state: Hebei
city: Wuhan
country: China
facility: Shenlong Hospital
state: Hebei
city: Harbin
country: China
facility: People's Hospital of Heilongjiang Province
state: Heilongjiang
city: Harbin
country: China
facility: The 2nd Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Harbin
country: China
facility: The First Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Harbin
country: China
facility: The First Affiliated Hospital of Heilongjiang University Of Chinese Medicine
state: Heilongjiang
city: Harbin
country: China
facility: The first hospital of Harbin City
state: Heilongjiang
city: Harbin
country: China
facility: The Fourth Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Harbin
country: China
facility: The Second Affiliated of Heilongjiang University of Chinese Medicine
state: Heilongjiang
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
city: Wuhan
country: China
facility: Wuhan Union Hospital
state: Hubei
city: Changsha
country: China
facility: Hunan Provincial People's Hospital
state: Hunan
city: Changsha
country: China
facility: The First Hospital of Changsha
state: Hunan
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: The Third Hospital of Changsha
state: Hunan
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital Central-South University
state: Hunan
city: Nanchang
country: China
facility: Jiangxi Provincial People's Hospital
state: Jiangxi
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Nanchang
country: China
facility: The Third Affiliated Hospital of Nanchang University
state: Jiangxi
city: Nanchang
country: China
facility: The Third Hospital of Nanchang
state: Jiangxi
city: Changchun
country: China
facility: Jilin Province People's Hospital
state: Jilin
city: Jilin
country: China
facility: Affiliated Hospital of Beihua University
state: Jilin
city: Shenyang
country: China
facility: General Hospital of Shenyang military area command of Chinese PLA
state: Liaoning
city: Shenyang
country: China
facility: Shenyang First People's Hospital
state: Liaoning
city: Shenyang
country: China
facility: Shenzhou Hospital to Shenyang Medical College
state: Liaoning
city: Shenyang
country: China
facility: The First Affiliated Hospital of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: The four six three hospital of people's Liberation Army
state: Liaoning
city: Shenyang
country: China
facility: The Fourth Affiliated Hospital of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: The people's Liberation Army 202nd hospital
state: Liaoning
city: Ankang
country: China
facility: Ankang City Central Hospital
state: Shaanxi
city: Hanzhong
country: China
facility: San Er Ling Yi Hospital
state: Shaanxi
city: Xi'an
country: China
facility: First Affiliated Hospital of Medical College of Xian Jiaotong University
state: Shaanxi
city: Xi'an
country: China
facility: Tangdu Hospital
state: Shaanxi
city: Xi'an
country: China
facility: The Central Hospital of Xi'an
state: Shaanxi
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
city: Binzhou
country: China
facility: Binzhou People's Hospital
state: Shandong
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
References: