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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Adverse Drug Reaction; Cinepazide

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 Products containing cinepazide have been withdrawn in 1990s by the manufacturers because of lacking of demonstrated efficacy and the risk of agranulocytosis in some European countries, such as France, Spain,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 Type: Observational
• Enrollment (Actual): 18260

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital
    • Beijing, Beijing, China, 100000
      • China Rehabilitation Research Center
    • Beijing, Beijing, China, 100000
      • Dongfang Hospital,the second clinical medical College of Beijing University of Chinese Medicine(BUCM)
    • Beijing, Beijing, China, 100005
      • Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
    • Beijing, Beijing, China, 100009
      • Fu Xing Hospital,Capital Medical University
    • Beijing, Beijing, China, 100011
      • Beijing Chuiyangliu Hospital(Beijing Minimally Invasive Hospital)
    • Beijing, Beijing, China, 100011
      • Hua Xin Hospital; First Hospital of Tsing Hua University
    • Beijing, Beijing, China, 100050
      • Xuanwu Hospital Affiliated to Capital Medical University
    • Beijing, Beijing, China, 100191
      • Beijing Shijitan Hospital,the 9th Clinical Medical College of Peking university
  • Gansu
    • Lanzhou, Gansu, China, 730000
      • Gansu Provincial Hospital
    • Lanzhou, Gansu, China, 730000
      • The First Affiliated Hospital of Lanzhou University
  • Guangdong
    • Ganjiang, Guangdong, China, 524000
      • Central People's Hospital of Zhanjiang
    • Gaozhou, Guangdong, China, 525200
      • The People's Hospital of Gaozhou
    • Guangzhou, Guangdong, China, 510000
      • Guangzhou First People's Hospital
    • Guangzhou, Guangdong, China, 510000
      • The Second Affiliated Hospital of Guangzhou Medical University
    • Guangzhou, Guangdong, China, 510000
      • Panyu Hospital of Chinese Medicine
    • Guangzhou, Guangdong, China, 510000
      • Sun Yat-Sen Memorial Hospital Sun Yat-sen University
    • Guangzhou, Guangdong, China, 510000
      • Zhujiang Hospital of Southern Medical University
    • Shantou, Guangdong, China, 510000
      • Shantou Central Hospital Affiliated Shantou Hospital of Sun Yan-Sen University
    • Shantou, Guangdong, China, 515000
      • The Second Affiliated Hospital Of Shantou University Medical College
    • Zhongshan, Guangdong, China, 528400
      • Hospital of Traditional Chinese Medicine of Zhongshan
  • Hebei
    • Wuhan, Hebei, China, 430040
      • People's Hospital of Dongxihu District
    • Wuhan, Hebei, China, 430050
      • Shenlong Hospital
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150000
      • The First Affiliated Hospital of Harbin Medical University
    • Harbin, Heilongjiang, China, 150000
      • People's Hospital of Heilongjiang Province
    • Harbin, Heilongjiang, China, 150000
      • The 2nd Affiliated Hospital of Harbin Medical University
    • Harbin, Heilongjiang, China, 150000
      • The First Affiliated Hospital of Heilongjiang University of Chinese Medicine
    • Harbin, Heilongjiang, China, 150000
      • The first hospital of Harbin City
    • Harbin, Heilongjiang, China, 150000
      • The Fourth Affiliated Hospital of Harbin Medical University
    • Harbin, Heilongjiang, China, 150000
      • The Second Affiliated of Heilongjiang University of Chinese Medicine
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Wuhan Union Hospital
    • Wuhan, Hubei, China, 430000
      • Renmin Hospital of Wuhan
    • Wuhan, Hubei, China, 430000
      • Tongji Hospital
  • Hunan
    • Changsha, Hunan, China, 410000
      • The Second Xiangya Hospital of Central South University
    • Changsha, Hunan, China, 410000
      • The Third Xiangya Hospital of Central South University
    • Changsha, Hunan, China, 410000
      • Xiangya Hospital Central-South University
    • Changsha, Hunan, China, 410000
      • The Third Hospital of Changsha
    • Changsha, Hunan, China, 410000
      • Hunan Provincial People's Hospital
    • Changsha, Hunan, China, 410000
      • The First Hospital of Changsha
  • Jiangxi
    • Nanchang, Jiangxi, China, 330000
      • The Second Affiliated Hospital of Nanchang University
    • Nanchang, Jiangxi, China, 330000
      • The First Affiliated Hospital of Nanchang University
    • Nanchang, Jiangxi, China, 330000
      • The Third Hospital of Nanchang
    • Nanchang, Jiangxi, China, 330000
      • Jiangxi Provincial People's Hospital
    • Nanchang, Jiangxi, China, 330000
      • The Third Affiliated Hospital of Nanchang University
  • Jilin
    • Changchun, Jilin, China, 130000
      • Jilin Province People's Hospital
    • Jilin, Jilin, China, 132000
      • Affiliated Hospital of Beihua University
  • Liaoning
    • Shenyang, Liaoning, China, 110000
      • The Fourth Affiliated Hospital of China Medical University
    • Shenyang, Liaoning, China, 110000
      • General Hospital of Shenyang military area command of Chinese PLA
    • Shenyang, Liaoning, China, 110000
      • Shenyang First People's Hospital
    • Shenyang, Liaoning, China, 110000
      • Shenzhou Hospital to Shenyang Medical College
    • Shenyang, Liaoning, China, 110000
      • The First Affiliated Hospital of China Medical University
    • Shenyang, Liaoning, China, 110000
      • The four six three hospital of people's Liberation Army
    • Shenyang, Liaoning, China, 110000
      • The people's Liberation Army 202nd hospital
  • Shaanxi
    • Ankang, Shaanxi, China, 725000
      • Ankang City Central Hospital
    • Hanzhong, Shaanxi, China, 723000
      • San Er Ling Yi Hospital
    • Xi'an, Shaanxi, China, 710000
      • Tangdu Hospital
    • Xi'an, Shaanxi, China, 710000
      • Xijing Hospital
    • Xi'an, Shaanxi, China, 710000
      • First Affiliated Hospital of Medical College of Xian jiaotong University
    • Xi'an, Shaanxi, China, 710000
      • The Central Hospital of Xi'an
  • Shandong
    • Binzhou, Shandong, China, 256600
      • Binzhou People's Hospital
    • Jinan, Shandong, China, 250000
      • Qilu Hospital of Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Inpatient using the cinepazide in the department of neurology in 61 hospitals in China.

Description

Inclusion Criteria:

• Inpatient using the cinepazide in the department of neurology

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
cinepazide; Inpatient using the cinepazide in department of neurology

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse drug reaction of cinepazide in department of neurology	1.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Outcomes of the patients who experienced an adverse drug reaction of cinepazide.	Outcomes including cure, improved, null, or death.	1.5 years
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
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
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: September 12, 2013
• First Submitted That Met QC Criteria: September 17, 2013
• First Posted (Estimate): September 20, 2013

Study Record Updates

• Last Update Posted (Actual): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 26, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Safety; Adverse Drug Reaction; Real World Study; Cinepazide
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: PekingUTH-Pharmacy-002