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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Peking University Third Hospital
Sponsor:
Collaborators:
Beijing Sihuan Pharmaceutical Co., Ltd
Beijing Shijitan Hospital,the 9th Clinical Medical College of Peking university
China Rehabilitation Research Center
Hua Xin Hospital First Hospital of Tsing Hua University
Fu Xing Hospital,Capital Medical University,China
Beijing Chuiyangliu Hospital(Beijing Minimally Invasive Hospital)
Dongfang Hospital, the Second Clinical Medical College of Beijing University of Chinese Medicine(BUCM)
Dongzhimen Hospital, Beijing
Xuanwu Hospital Affiliated to Capital Medical University,China
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Southern Medical University, China
Guangzhou First Municipal People’s Hospital
Panyu Hospital of Chinese Medicine
Second Affiliated Hospital of Guangzhou Medical University
The People's Hospital of Gaozhou
Hospital of Traditional Chinese Medicine of Zhongshan
The Second Affiliated Hospital of Shantou University Medical College
Shantou Central Hospital Affiliated Shantou Hospital of Sun Yan-Sen University
Central People's Hospital of Zhanjiang
Wuhan Union Hospital, China
Tongji Hospital
Renmin Hospital of Wuhan University
People's Hospital of Dongxihu District
Shenlong Hospital
Xiangya Hospital of Central South University
Central South University
The Third Xiangya Hospital of Central South University
Hunan Provincial People's Hospital
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
The Third Hospital of Changsha
Ankang City Central Hospital
San Er Ling Yi Hospital
Xijing Hospital
Tang-Du Hospital
First Affiliated Hospital Xi'an Jiaotong University
Gansu Provincial Hospital
The Central Hospital of Xi'an
LanZhou University
Qilu Hospital
Binzhou People's Hospital
Jiangxi Provincial People's Hospital
The First Affiliated Hospital of Nanchang University
Second Affiliated Hospital of Nanchang University
The Third Affiliated Hospital of Nanchang University
The Third Hospital of Nanchang
First Affiliated Hospital of Harbin Medical University
First Affiliated Hospital of Heilongjiang Chinese Medicine University
People's Hospital of Heilongjiang Province
The Second Affiliated Hospital of Harbin Medical University
The first hospital of Harbin City
The Fourth Affiliated Hospital of Harbin Medical University
The Second Affiliated of Heilongjiang University of Chinese Medicine
China Medical University, China
The people's Liberation Army 202nd hospital
The Fourth Affiliated Hospital of China Medical University
General Hospital of Shenyang military area command of Chinese PLA
The four six three hospital of people's Liberation Army
First People's Hospital of Shenyang
Jilin Province People's Hospital
Beihua University
Shenzhou Hospital to Shenyang Medical College
Information provided by (Responsible Party):
Suodi ZHAI, Peking University Third Hospital
ClinicalTrials.gov Identifier:
NCT01946919
First received: September 12, 2013
Last updated: November 30, 2013
Last verified: November 2013

September 12, 2013
November 30, 2013
October 2012
June 2014   (final data collection date for primary outcome measure)
Incidence of adverse drug reaction of cinepazide in department of neurology [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01946919 on ClinicalTrials.gov Archive Site
  • Outcomes of the patients who experienced an adverse drug reaction of cinepazide. [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
    Outcomes including cure, improved, null, or death.
  • The predictors of the adverse drug reaction of cinepazide [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
    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.
  • Types of the adverse drug reaction of cinepazide. [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
    The types of the adverse drug reaction of cinepazide including Nausea, vomiting, itching and etc.
  • The treatment when patients experienced an adverse drug reaction of cinepazide. [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
    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.
Same as current
Not Provided
Not Provided
 
Post-Marketing Surveillance of the Cinepazide Maleate Injection: a Real World Study
Post-Marketing Surveillance of the Cinepazide Maleate Injection: a Real World Study

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.

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.

Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
14 Days
Not Provided
Non-Probability Sample

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

  • Adverse Drug Reaction
  • Cinepazide
  • Stroke
Not Provided
cinepazide
Inpatient using the cinepazide in department of neurology
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
18000
June 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Inpatient using the cinepazide in the department of neurology

Exclusion Criteria:

  • none
Both
Not Provided
No
Contact: Suodi ZHAI, BS +8615611908515 zhaisuodi@163.com
China
 
NCT01946919
PekingUTH-Pharmacy-002
Yes
Suodi ZHAI, Peking University Third Hospital
Peking University Third Hospital
  • Beijing Sihuan Pharmaceutical Co., Ltd
  • Beijing Shijitan Hospital,the 9th Clinical Medical College of Peking university
  • China Rehabilitation Research Center
  • Hua Xin Hospital First Hospital of Tsing Hua University
  • Fu Xing Hospital,Capital Medical University,China
  • Beijing Chuiyangliu Hospital(Beijing Minimally Invasive Hospital)
  • Dongfang Hospital, the Second Clinical Medical College of Beijing University of Chinese Medicine(BUCM)
  • Dongzhimen Hospital, Beijing
  • Xuanwu Hospital Affiliated to Capital Medical University,China
  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  • Southern Medical University, China
  • Guangzhou First Municipal People’s Hospital
  • Panyu Hospital of Chinese Medicine
  • Second Affiliated Hospital of Guangzhou Medical University
  • The People's Hospital of Gaozhou
  • Hospital of Traditional Chinese Medicine of Zhongshan
  • The Second Affiliated Hospital of Shantou University Medical College
  • Shantou Central Hospital Affiliated Shantou Hospital of Sun Yan-Sen University
  • Central People's Hospital of Zhanjiang
  • Wuhan Union Hospital, China
  • Tongji Hospital
  • Renmin Hospital of Wuhan University
  • People's Hospital of Dongxihu District
  • Shenlong Hospital
  • Xiangya Hospital of Central South University
  • Central South University
  • The Third Xiangya Hospital of Central South University
  • Hunan Provincial People's Hospital
  • The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
  • The Third Hospital of Changsha
  • Ankang City Central Hospital
  • San Er Ling Yi Hospital
  • Xijing Hospital
  • Tang-Du Hospital
  • First Affiliated Hospital Xi'an Jiaotong University
  • Gansu Provincial Hospital
  • The Central Hospital of Xi'an
  • LanZhou University
  • Qilu Hospital
  • Binzhou People's Hospital
  • Jiangxi Provincial People's Hospital
  • The First Affiliated Hospital of Nanchang University
  • Second Affiliated Hospital of Nanchang University
  • The Third Affiliated Hospital of Nanchang University
  • The Third Hospital of Nanchang
  • First Affiliated Hospital of Harbin Medical University
  • First Affiliated Hospital of Heilongjiang Chinese Medicine University
  • People's Hospital of Heilongjiang Province
  • The Second Affiliated Hospital of Harbin Medical University
  • The first hospital of Harbin City
  • The Fourth Affiliated Hospital of Harbin Medical University
  • The Second Affiliated of Heilongjiang University of Chinese Medicine
  • China Medical University, China
  • The people's Liberation Army 202nd hospital
  • The Fourth Affiliated Hospital of China Medical University
  • General Hospital of Shenyang military area command of Chinese PLA
  • The four six three hospital of people's Liberation Army
  • First People's Hospital of Shenyang
  • Jilin Province People's Hospital
  • Beihua University
  • Shenzhou Hospital to Shenyang Medical College
Not Provided
Peking University Third Hospital
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP