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

July 26, 2022 updated by: Suodi ZHAI, Peking University Third Hospital
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Products containing cinepazide have been withdrawn in 1990s by the manufacturers because of lacking of demonstrated efficacy and the risk of agranulocytosis in some European countries, such as France, Spain,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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18260

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
cinepazide
Inpatient using the cinepazide in department of neurology

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Incidence of adverse drug reaction of cinepazide in department of neurology
Time Frame: 1.5 years
1.5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Outcomes of the patients who experienced an adverse drug reaction of cinepazide.
Time Frame: 1.5 years
Outcomes including cure, improved, null, or death.
1.5 years
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.
1.5 years
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.
1.5 years
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.
1.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University Third Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 12, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 20, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PekingUTH-Pharmacy-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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