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
  Purpose

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.


Condition
Adverse Drug Reaction
Cinepazide
Stroke

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 14 Days
Official Title: Post-Marketing Surveillance of the Cinepazide Maleate Injection: a Real World Study

Further study details as provided by Peking University Third Hospital:

Primary Outcome Measures:
  • Incidence of adverse drug reaction of cinepazide in department of neurology [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 18000
Study Start Date: October 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
cinepazide
Inpatient using the cinepazide in department of neurology

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • Inpatient using the cinepazide in the department of neurology

Exclusion Criteria:

  • none
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01946919

Contacts
Contact: Suodi ZHAI, BS +8615611908515 zhaisuodi@163.com

  Hide Study Locations
Locations
China, Beijing
Peking University Third Hospital Recruiting
Beijing, Beijing, China, 100191
Contact: Suodi ZHAI, B.S.    +8615611908515    zhaisuodi@163.com   
Principal Investigator: Suodi ZHAI,, B.S.         
Beijing Shijitan Hospital,the 9th Clinical Medical College of Peking university Recruiting
Beijing, Beijing, China, 100191
Contact: Lulu Sun    +8613901350158      
Principal Investigator: Lulu Sun         
China Rehabilitation Research Center Recruiting
Beijing, Beijing, China, 100000
Contact: Jun GAO    +8613811050011      
Principal Investigator: Jun GAO         
Dongfang Hospital,the second clinical medical College of Beijing University of Chinese Medicine(BUCM) Recruiting
Beijing, Beijing, China, 100000
Contact: Guodong HUA    +8613683135764      
Principal Investigator: Guodong HUA         
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine Recruiting
Beijing, Beijing, China, 100005
Contact: Junling CAO    +8613681334596      
Principal Investigator: Junling CAO         
Beijing Chuiyangliu Hospital(Beijing Minimally Invasive Hospital) Recruiting
Beijing, Beijing, China, 100011
Contact: Wengbin XIA    (+86)13521000428      
Principal Investigator: Wengbin XIA         
Hua Xin Hospital; First Hospital of Tsing Hua University Recruiting
Beijing, Beijing, China, 100011
Contact: Jianying WEI    +8615901496680      
Principal Investigator: Jianying WEI         
Fu Xing Hospital,Capital Medical University Recruiting
Beijing, Beijing, China, 100009
Contact: Hong JIANG    (+86)18618238593      
Principal Investigator: Hong JIANG         
Xuanwu Hospital Affiliated to Capital Medical University Recruiting
Beijing, Beijing, China, 100050
Contact: Suying YAN    +8613718905057      
Principal Investigator: Suying YAN         
China, Gansu
Gansu Provincial Hospital Recruiting
Lanzhou, Gansu, China, 730000
Contact: Bin GE    +86 0931-8281345      
Principal Investigator: Bin GE         
The First Affiliated Hospital of Lanzhou University Recruiting
Lanzhou, Gansu, China, 730000
Contact: Yongfang HE    +8613609345198      
Principal Investigator: Yongfang HE         
China, Guangdong
Central People's Hospital of Zhanjiang Recruiting
Ganjiang, Guangdong, China, 524000
Contact: Kunping LAI    +8613828257182      
Principal Investigator: Kunping LAI         
The People's Hospital of Gaozhou Recruiting
Gaozhou, Guangdong, China, 525200
Contact: Zengchao DENG    +8613600398181      
Principal Investigator: Zengchao DENG         
Sun Yat-Sen Memorial Hospital Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Jianfang LI    +8613826284816      
Principal Investigator: Jianfang LI         
Panyu Hospital of Chinese Medicine Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Jianfen SU    +8615902090732      
Principal Investigator: Jianfen SU         
ZhuJiang Hospital of Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Yong WANG    +8613424090885      
Principal Investigator: Yong WANG         
GuangZhou First People's Hospital Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Huiqin NI    +862081048106      
Principal Investigator: Huiqin NI         
The Second Affiliated Hospital of Guangzhou Medical University Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Ruolun WANG    +8618926298683      
Principal Investigator: Ruolun WANG         
The Second Affiliated Hospital of Shantou University Medical College Recruiting
Shantou, Guangdong, China, 515000
Contact: Hongbo FU    +8613118686338      
Principal Investigator: Hongbo FU         
Shantou Central Hospital Affiliated Shantou Hospital of Sun Yan-Sen University Recruiting
Shantou, Guangdong, China, 510000
Contact: Qingnan LI    +8613501410369      
Principal Investigator: Qingnan LI         
Hospital of Traditional Chinese Medicine of Zhongshan Recruiting
Zhongshan, Guangdong, China, 528400
Contact: Xueqin Li    +8613420299042      
Principal Investigator: Xueqin LI         
China, Hebei
People's Hospital of Dongxihu District Recruiting
Wuhan, Hebei, China, 430040
Contact: Jichuan HU    +8615971426889      
Principal Investigator: Jichuan HU         
Shenlong Hospital Recruiting
Wuhan, Hebei, China, 430050
Contact: Lingling ZHANG    +8613995508561      
Principal Investigator: Lingling ZHANG         
China, Heilongjiang
The First Affiliated Hospital of Harbin Medical University Recruiting
Harbin, Heilongjiang, China, 150000
Contact: Jinlong ZHANG    +8613945005850      
Principal Investigator: Jinlong ZHANG         
The First Affiliated Hospital of Heilongjiang University Of Chinese Medicine Recruiting
Harbin, Heilongjiang, China, 150000
Contact: Dequan WANG    +8618045183337      
Principal Investigator: Dequan WANG         
People's Hospital of Heilongjiang Province Recruiting
Harbin, Heilongjiang, China, 150000
Contact: Hongyu LIU    +8618646026985      
Principal Investigator: Hongyu LIU         
The 2nd Affiliated Hospital of Harbin Medical University Recruiting
Harbin, Heilongjiang, China, 150000
Contact: Dongqiang WANG    +8613504847515      
Principal Investigator: Dongqiang WANG         
The first hospital of Harbin City Recruiting
Harbin, Heilongjiang, China, 150000
Contact: Xin LIU    +8613654554735      
Principal Investigator: Xin LIU         
The Fourth Affiliated Hospital of Harbin Medical University Recruiting
Harbin, Heilongjiang, China, 150000
Contact: Wei WANG    +8615946006382      
Principal Investigator: Wei WANG         
The Second Affiliated of Heilongjiang University of Chinese Medicine Recruiting
Harbin, Heilongjiang, China, 150000
Contact: Xiangyang LI    +8613613604283      
Principal Investigator: Xiangyang LI         
China, Hubei
Wuhan Union Hospital Recruiting
Wuhan, Hubei, China, 430000
Contact: Pu HUANG    +8613307177169      
Principal Investigator: Pu HUANG         
Tongji Hospital Recruiting
Wuhan, Hubei, China, 430000
Contact: Guang DU    +8613707163126      
Principal Investigator: Guang DU         
Renmin Hospital of Wuhan Recruiting
Wuhan, Hubei, China, 430000
Contact: Jinchun SONG    +8613971608052      
Principal Investigator: Jinchun SONG         
China, Hunan
Xiangya Hospital Central-South University Recruiting
Changsha, Hunan, China, 410000
Contact: Tao YIN    +86 0731-84327918      
Principal Investigator: Tao YIN         
The Second Xiangya Hospital of Central South University Recruiting
Changsha, Hunan, China, 410000
Contact: Huande LI    +8613908484372      
Principal Investigator: Huande LI         
The Third Xiangya Hospital of Central South University Recruiting
Changsha, Hunan, China, 410000
Contact: Shikun LIU    +8613708484372      
Principal Investigator: Shikun LIU         
Hunan Provincial People's Hospital Recruiting
Changsha, Hunan, China, 410000
Contact: Yinhua DENG    +8613755058626      
Principal Investigator: Yinhua DENG         
The First Hospital of Changsha Recruiting
Changsha, Hunan, China, 410000
Contact: Heng CHEN    +8613975829501      
Principal Investigator: Heng CHEN         
The Third Hospital of Changsha Recruiting
Changsha, Hunan, China, 410000
Contact: Li ZHANG    +86 0731-85171383      
Principal Investigator: Li ZHANG         
China, Jiangxi
Jiangxi Provincial People's Hospital Recruiting
Nanchang, Jiangxi, China, 330000
Contact: Dan XI XI    +8613870959956      
Principal Investigator: Dan XI         
The First Affiliated Hospital of Nanchang University Recruiting
Nanchang, Jiangxi, China, 330000
Contact: Xiaohua WEI    +8613803523639      
Principal Investigator: Xiaohua WEI         
The Second Affiliated Hospital of Nanchang University Recruiting
Nanchang, Jiangxi, China, 330000
Contact: Shegui LU    +8613707091666      
Principal Investigator: Shegui LU         
The Third Affiliated Hospital of Nanchang University Recruiting
Nanchang, Jiangxi, China, 330000
Contact: Meifeng LUO    +8613117818297      
Principal Investigator: Meifeng LUO         
The Third Hospital of Nanchang Recruiting
Nanchang, Jiangxi, China, 330000
Contact: Li CHEN    +8613870838017      
Principal Investigator: Li CHEN         
China, Jilin
Jilin Province People's Hospital Recruiting
Changchun, Jilin, China, 130000
Contact: Lijun XU    +8615843076650      
Principal Investigator: Lijun XU         
Affiliated Hospital of Beihua University Recruiting
Jilin, Jilin, China, 132000
Contact: Jinhuan LI    +8613843270019      
Principal Investigator: Jinhuan LI         
China, Liaoning
The First Affiliated Hospital of China Medical University Recruiting
Shenyang, Liaoning, China, 110000
Contact: Mingyan JIANG    +8613940479985      
Principal Investigator: Mingyan JIANG         
The people's Liberation Army 202nd hospital Recruiting
Shenyang, Liaoning, China, 110000
Contact: Xiaoli ZHANG    +8613352450178      
Principal Investigator: Xiaoli ZHANG         
The Fourth Affiliated Hospital of China Medical University Recruiting
Shenyang, Liaoning, China, 110000
Contact: Guiyuan CHEN    +8615840211331      
Principal Investigator: Guiyuan CHEN         
General Hospital of Shenyang military area command of Chinese PLA Recruiting
Shenyang, Liaoning, China, 110000
Contact: Huisheng CHEN    +8613352452086      
Principal Investigator: Huisheng CHEN         
The four six three hospital of people's Liberation Army Recruiting
Shenyang, Liaoning, China, 110000
Contact: Yang MA    +8618909822630      
Principal Investigator: Yang MA         
Shenyang First People's Hospital Recruiting
Shenyang, Liaoning, China, 110000
Contact: Yongchang ZHENG    +8615640109305      
Principal Investigator: Yongchang ZHENG         
Shenzhou Hospital to Shenyang Medical College Recruiting
Shenyang, Liaoning, China, 110000
Contact: Yi LU    +8613840018161      
Principal Investigator: Yi LU         
China, Shaanxi
Ankang City Central Hospital Recruiting
Ankang, Shaanxi, China, 725000
Contact: Wei HUANG    +8613709156888      
Principal Investigator: Wei HUANG         
San Er Ling Yi Hospital Recruiting
Hanzhong, Shaanxi, China, 723000
Contact: Duoxiang WEI    +8613992660316      
Principal Investigator: Duoxiang WEI         
Xijing Hospital Recruiting
Xi'an, Shaanxi, China, 710000
Contact: yanyan JIA    +8618691555435      
Principal Investigator: yanyan JIA         
Tangdu Hospital Recruiting
Xi'an, Shaanxi, China, 710000
Contact: Lina LIU    +8613571851741      
Principal Investigator: Lina LIU         
First Affiliated Hospital of Medical College of Xian Jiaotong University Recruiting
Xi'an, Shaanxi, China, 710000
Contact: Yalin DONG    +86 029-85323241      
Principal Investigator: Yalin DONG         
The Central Hospital of Xi'an Recruiting
Xi'an, Shaanxi, China, 710000
Contact: Jianwei HE    +8613991875765      
Principal Investigator: Jianwei HE         
China, Shandong
Binzhou People's Hospital Recruiting
Binzhou, Shandong, China, 256600
Contact: Zhenhong HUO    +86 15254349506      
Principal Investigator: Zhenhong HUO         
Qilu Hospital of Shandong University Recruiting
Jinan, Shandong, China, 250000
Contact: Wen ZHOU    +86 0531-82169066      
Principal Investigator: Wen ZHOU         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Suodi ZHAI, Suodi ZHAI, Department of Pharmacy, Peking University Third Hospital, Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT01946919     History of Changes
Other Study ID Numbers: PekingUTH-Pharmacy-002
Study First Received: September 12, 2013
Last Updated: November 30, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Peking University Third Hospital:
Cinepazide
Adverse Drug Reaction
Safety
Real World Study

Additional relevant MeSH terms:
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on September 18, 2014