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NCT Number: NCT01946919

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.

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Key information

Conditions

Adverse Drug Reaction Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chemically-Induced Disorders Cinepazide Drug-Related Side Effects and Adverse Reactions Nervous System Diseases Stroke Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Chuiyangliu Hospital(Beijing Minimally Invasive Hospital), Beijing, Beijing Municipality, China

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About this study

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 Products containing cinepazide have been withdrawn in 1990s by the manufacturers because of lacking of demonstrated efficacy and the risk of agranulocytosis in some European countries, such as France, Spain,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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Inpatient using the cinepazide in the department of neurology

Exclusion criteria

  • none

Treatment and study plan

Primary outcomes

  1. Incidence of adverse drug reaction of cinepazide in department of neurology

    Time frame: 1.5 years

Secondary outcomes

  1. Outcomes of the patients who experienced an adverse drug reaction of cinepazide.

    Time frame: 1.5 years

    Outcomes including cure, improved, null, or death.

  2. The predictors of the adverse drug reaction of cinepazide

    Time frame: 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.

  3. Types of the adverse drug reaction of cinepazide.

    Time frame: 1.5 years

    The types of the adverse drug reaction of cinepazide including Nausea, vomiting, itching and etc.

  4. The treatment when patients experienced an adverse drug reaction of cinepazide.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Collaborators

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

Registry information

Acronym: PACER

Important dates

Study start
2012
Primary completion
2021
Study completion
2022
First posted
Sep 20, 2013
Registry last updated
Jul 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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