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

Completed

• Conditions: Adverse Drug Reaction; Cinepazide; Stroke

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 Products containing cinepazide have been withdrawn in 1990s by the manufacturers because of lacking of demonstrated efficacy and the risk of agranulocytosis in some European countries, such as France, Spain,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

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-09-12
• Study First Submitted QC: 2013-09-17
• Study First Posted: 2013-09-20
• Primary Completion: 2021-12
• Study Completion: 2022-06
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-26
• Last Update Posted: 2022-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18260

Inclusion Criteria

• Inpatient using the cinepazide in the department of neurology

Exclusion Criteria

• 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