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

Resource links provided by NLM:


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

  Show 61 Study Locations
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:
Stroke
Drug-Related Side Effects and Adverse Reactions
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Chemically-Induced Disorders
Maleic acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014