Post-Marketing Surveillance of the Cinepazide Maleate Injection: a Real World Study

Stroke Clinical Trial

— PACER  

Official title:

Post-Marketing Surveillance of the Cinepazide Maleate Injection: a Real World Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01946919
• Other study ID #: PekingUTH-Pharmacy-002
• Status: Completed
• Start date: October 2012
• Est. completion date: June 2022

Study information

• Verified date: July 2022
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 Products containing cinepazide have been withdrawn in 1990s by the manufacturers because of lacking of demonstrated efficacy and the risk of agranulocytosis in some European countries, such as France, Spain,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 information / eligibility

• Status: Completed
• Enrollment: 18260
• Est. completion date: June 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Inpatient using the cinepazide in the department of neurology

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Adverse Drug Reaction
• Cinepazide
• Drug-Related Side Effects and Adverse Reactions
• Stroke

Locations

Country	Name	City	State
China	Ankang City Central Hospital	Ankang	Shaanxi
China	Beijing Chuiyangliu Hospital(Beijing Minimally Invasive Hospital)	Beijing	Beijing
China	Beijing Shijitan Hospital,the 9th Clinical Medical College of Peking university	Beijing	Beijing
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	Fu Xing Hospital,Capital Medical University	Beijing	Beijing
China	Hua Xin Hospital; First Hospital of Tsing Hua University	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	Xuanwu Hospital Affiliated to Capital Medical University	Beijing	Beijing
China	Binzhou People's Hospital	Binzhou	Shandong
China	Jilin Province People's Hospital	Changchun	Jilin
China	Hunan Provincial People's Hospital	Changsha	Hunan
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	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	San Er Ling Yi Hospital	Hanzhong	Shaanxi
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 Fourth Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	The Second Affiliated of Heilongjiang University of Chinese Medicine	Harbin	Heilongjiang
China	Affiliated Hospital of Beihua University	Jilin	Jilin
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	Gansu Provincial Hospital	Lanzhou	Gansu
China	The First Affiliated Hospital of Lanzhou University	Lanzhou	Gansu
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	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	General Hospital of Shenyang military area command of Chinese PLA	Shenyang	Liaoning
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 four six three hospital of people's Liberation Army	Shenyang	Liaoning
China	The Fourth Affiliated Hospital of China Medical University	Shenyang	Liaoning
China	The people's Liberation Army 202nd hospital	Shenyang	Liaoning
China	People's Hospital of Dongxihu District	Wuhan	Hebei
China	Renmin Hospital of Wuhan	Wuhan	Hubei
China	Shenlong Hospital	Wuhan	Hebei
China	Tongji Hospital	Wuhan	Hubei
China	Wuhan Union Hospital	Wuhan	Hubei
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	Hospital of Traditional Chinese Medicine of Zhongshan	Zhongshan	Guangdong

Sponsors (62)

Lead Sponsor

Collaborator

Peking University Third Hospital

Ankang City Central Hospital, Beihua University, Beijing Chuiyangliu Hospital(Beijing Minimally Invasive Hospital), Beijing Shijitan Hospital,the 9th Clinical Medical College of Peking university, Beijing Sihuan Pharmaceutical Co. Ltd., Binzhou People's Hospital, Central People's Hospital of Zhanjiang, Central South University, China Rehabilitation Research Center, Dongfang Hospital Beijing University of Chinese Medicine, Dongzhimen Hospital, Beijing, First Affiliated Hospital of Harbin Medical University, First Affiliated Hospital of Heilongjiang Chinese Medicine University, First Affiliated Hospital Xi'an Jiaotong University, First Hospital of China Medical University, First People's Hospital of Shenyang, Fu Xing Hospital, Capital Medical University, Gansu Provincial Hospital, General Hospital of Shenyang Military Region, Guangzhou First People's Hospital, Hua Xin Hospital First Hospital of Tsing Hua University, Hunan Provincial People's Hospital, Jiangxi Provincial People's Hopital, Jilin Province People's Hospital, LanZhou University, Panyu Hospital of Traditional Chinese Medicine, People's Hospital of Dongxihu District, People's Hospital of Heilongjiang Province, People's Liberation Army No.202 Hospital, Qilu Hospital of Shandong University, Renmin Hospital of Wuhan University, San Er Ling Yi Hospital, Second Affiliated Hospital of Guangzhou Medical University, Second Affiliated Hospital of Heilongjiang University of Chinese Medicine, Second Affiliated Hospital of Nanchang University, Shenlong Hospital, Shenzhou Hospital to Shenyang Medical College, Southern Medical University, China, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Sun Yat-sen University, Tang-Du Hospital, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, The First Affiliated Hospital of Nanchang University, The first hospital of Harbin City, The four six three hospital of people's Liberation Army, The Fourth Affiliated Hospital of China Medical University, The Fourth Affiliated Hospital of Harbin Medical University, The People's Hospital of Gaozhou, The Second Affiliated Hospital of Harbin Medical University, The Second Affiliated Hospital of Shantou University Medical College, The Third Affiliated Hospital of Nanchang University, The Third Hospital of Changsha, The Third Hospital of Nanchang, The Third Xiangya Hospital of Central South University, Tongji Hospital, Wuhan Union Hospital, China, Xi'an Central Hospital, Xiangya Hospital of Central South University, Xijing Hospital, Xuanwu Hospital, Beijing, Zhongshan Hospital Of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse drug reaction of cinepazide in department of neurology		1.5 years
Secondary	Outcomes of the patients who experienced an adverse drug reaction of cinepazide.	Outcomes including cure, improved, null, or death.	1.5 years
Secondary	The predictors of the adverse drug reaction of cinepazide	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.	1.5 years
Secondary	Types of the adverse drug reaction of cinepazide.	The types of the adverse drug reaction of cinepazide including Nausea, vomiting, itching and etc.	1.5 years
Secondary	The treatment when patients experienced an adverse drug reaction of cinepazide.	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.	1.5 years