Adverse Drug ReactionPACERNCT01946919
Post-Marketing Surveillance of the Cinepazide Maleate Injection: a Real World Study
An observational study of Adverse Drug Reaction and Cinepazide, run by Peking University Third Hospital at 61 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adverse Drug Reaction, Cinepazide, Stroke
- How many people
- 18,260 participants
- Where
- 61 sitesChina
- Study dates
- Oct 2012to Jun 2022
- How long will I take part?
- 14 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Inpatient using the cinepazide in the department of neurology in 61 hospitals in China.
Who may be able to join
- Inpatient using the cinepazide in the department of neurology
Who cannot join
- none
Trial locations and contacts
61 sites in 1 country.
61 sites in 1 country
China61 sites
Ankang City Central Hospital
Ankang, Shaanxi, 725000
China Rehabilitation Research Center
Beijing, Beijing Municipality, 100000
Dongfang Hospital,the second clinical medical College of Beijing University of Chinese Medicine(BUCM)
Beijing, Beijing Municipality, 100000
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Beijing, Beijing Municipality, 100005
Fu Xing Hospital,Capital Medical University
Beijing, Beijing Municipality, 100009
Beijing Chuiyangliu Hospital(Beijing Minimally Invasive Hospital)
Beijing, Beijing Municipality, 100011
Hua Xin Hospital; First Hospital of Tsing Hua University
Beijing, Beijing Municipality, 100011
Xuanwu Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 100050
Beijing Shijitan Hospital,the 9th Clinical Medical College of Peking university
Beijing, Beijing Municipality, 100191
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Binzhou People's Hospital
Binzhou, Shandong, 256600
Jilin Province People's Hospital
Changchun, Jilin, 130000
Hunan Provincial People's Hospital
Changsha, Hunan, 410000
The First Hospital of Changsha
Changsha, Hunan, 410000
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410000
The Third Hospital of Changsha
Changsha, Hunan, 410000
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410000
Xiangya Hospital Central-South University
Changsha, Hunan, 410000
Central People's Hospital of Zhanjiang
Ganjiang, Guangdong, 524000
The People's Hospital of Gaozhou
Gaozhou, Guangdong, 525200
GuangZhou First People's Hospital
Guangzhou, Guangdong, 510000
Panyu Hospital of Chinese Medicine
Guangzhou, Guangdong, 510000
Sun Yat-Sen Memorial Hospital Sun Yat-Sen University
Guangzhou, Guangdong, 510000
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510000
ZhuJiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510000
San Er Ling Yi Hospital
Hanzhong, Shaanxi, 723000
People's Hospital of Heilongjiang Province
Harbin, Heilongjiang, 150000
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150000
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150000
The First Affiliated Hospital of Heilongjiang University Of Chinese Medicine
Harbin, Heilongjiang, 150000
The first hospital of Harbin City
Harbin, Heilongjiang, 150000
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150000
The Second Affiliated of Heilongjiang University of Chinese Medicine
Harbin, Heilongjiang, 150000
Affiliated Hospital of Beihua University
Jilin City, Jilin, 132000
Qilu Hospital of Shandong University
Jinan, Shandong, 250000
Gansu Provincial Hospital
Lanzhou, Gansu, 730000
The First Affiliated Hospital of Lanzhou University
Lanzhou, Gansu, 730000
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330000
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330000
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330000
The Third Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330000
The Third Hospital of Nanchang
Nanchang, Jiangxi, 330000
Shantou Central Hospital Affiliated Shantou Hospital of Sun Yan-Sen University
Shantou, Guangdong, 510000
The Second Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, 515000
General Hospital of Shenyang military area command of Chinese PLA
Shenyang, Liaoning, 110000
Shenyang First People's Hospital
Shenyang, Liaoning, 110000
Shenzhou Hospital to Shenyang Medical College
Shenyang, Liaoning, 110000
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110000
The four six three hospital of people's Liberation Army
Shenyang, Liaoning, 110000
The Fourth Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110000
The people's Liberation Army 202nd hospital
Shenyang, Liaoning, 110000
People's Hospital of Dongxihu District
Wuhan, Hebei, 430040
Shenlong Hospital
Wuhan, Hebei, 430050
Renmin Hospital of Wuhan
Wuhan, Hubei, 430000
Tongji Hospital
Wuhan, Hubei, 430000
Wuhan Union Hospital
Wuhan, Hubei, 430000
First Affiliated Hospital of Medical College of Xian Jiaotong University
Xi'an, Shaanxi, 710000
Tangdu Hospital
Xi'an, Shaanxi, 710000
The Central Hospital of Xi'an
Xi'an, Shaanxi, 710000
Xijing Hospital
Xi'an, Shaanxi, 710000
Hospital of Traditional Chinese Medicine of Zhongshan
Zhongshan, Guangdong, 528400
About this 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.
Read the 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.
- Conditions
- Adverse Drug Reaction, Cinepazide, Stroke
- Keywords
- Cinepazide, Adverse Drug Reaction, Safety, Real World Study
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cinepazide | Inpatient using the cinepazide in department of neurology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse drug reaction of cinepazide in department of neurology
Measured: 1.5 years
Secondary outcomes (4)
Outcomes of the patients who experienced an adverse drug reaction of cinepazide.
Outcomes including cure, improved, null, or death.
Measured: 1.5 years
The predictors of the adverse drug reaction of cinepazide
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.
Measured: 1.5 years
Types of the adverse drug reaction of cinepazide.
The types of the adverse drug reaction of cinepazide including Nausea, vomiting, itching and etc.
Measured: 1.5 years
The treatment when patients experienced an adverse drug reaction of cinepazide.
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.
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startOct 2012
- Primary completionDec 2021
- Study completionJun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Drug ReactionStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18,260 participants (actual)
- Target duration
- 14 Days
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Sihuan Pharmaceutical Co. Ltd., China Rehabilitation Research Center, Beijing Huaxin Hospital, Fu Xing Hospital, Capital Medical University, Dongfang Hospital Beijing University of Chinese Medicine, Dongzhimen Hospital, Beijing, Xuanwu Hospital, Beijing, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Southern Medical University, China, Guangzhou First People's Hospital, Panyu Hospital of Traditional Chinese Medicine, Second Affiliated Hospital of Guangzhou Medical University, The People's Hospital of Gaozhou, Zhongshan Hospital Of Traditional Chinese Medicine, Second Affiliated Hospital of Shantou University Medical College, Sun Yat-sen University, Central People's Hospital of Zhanjiang, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Tongji Hospital, Renmin Hospital of Wuhan University, Xiangya Hospital of Central South University, Second Xiangya Hospital of 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, Changsha Third Hospital, Ankang City Central Hospital, Xijing Hospital, Tang-Du Hospital, First Affiliated Hospital Xi'an Jiaotong University, Gansu Provincial Hospital, LanZhou University, Qilu Hospital of Shandong University, Binzhou People's Hospital, Jiangxi Provincial People's Hopital, The First Affiliated Hospital of Nanchang University, Second Affiliated Hospital of Nanchang University, The Third Affiliated Hospital of Nanchang University, The Second Affiliated Hospital of Harbin Medical University, The Fourth Affiliated Hospital of Harbin Medical University, Second Affiliated Hospital of Heilongjiang University of Chinese Medicine, First People's Hospital of Shenyang, Jilin Provincial People's Hospital, Beihua University, Beijing Shijitan Hospital, Capital Medical University, Beijing Chuiyangliu Hospital, Longgang District People's Hospital of Shenzhen, Xi'an Central Hospital, Nanchang Third Hospital, First Affiliated Hospital of Harbin Medical University, First Affiliated Hospital of Heilongjiang Chinese Medicine University, Heilongjiang Provicial Hospital, First Hospital of China Medical University, No 202 hospital of PLA, The Fourth Affiliated Hospital of China Medical University, The General Hospital of Northern Theater Command, Central Hospital Affiliated to Shenyang Medical Collage, Wuhan Dongxihu District People's Hospital, 3201 Hospital, No 463 Hospital of PLA
- Responsible party
- Principal investigator, Suodi ZHAI, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01946919
- Sponsor's protocol ID
- PekingUTH-Pharmacy-002
- Acronym
- PACER
- Status last verified
- Oct 2026
- First submitted
- 12 Sep 2013
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Surveillance of the Cinepazide Maleate Injection: a Real World Study
- ClinicalTrials.gov ID
- NCT01946919
- Acronym / sponsor ID
- PACER / PekingUTH-Pharmacy-002
- Conditions
- Adverse Drug Reaction, Cinepazide, Stroke
- Keywords
- Cinepazide, Adverse Drug Reaction, Safety, Real World Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18,260 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Beijing Sihuan Pharmaceutical Co. Ltd., China Rehabilitation Research Center, Beijing Huaxin Hospital, Fu Xing Hospital, Capital Medical University, Dongfang Hospital Beijing University of Chinese Medicine, Dongzhimen Hospital, Beijing, Xuanwu Hospital, Beijing, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Southern Medical University, China, Guangzhou First People's Hospital, Panyu Hospital of Traditional Chinese Medicine, Second Affiliated Hospital of Guangzhou Medical University, The People's Hospital of Gaozhou, Zhongshan Hospital Of Traditional Chinese Medicine, Second Affiliated Hospital of Shantou University Medical College, Sun Yat-sen University, Central People's Hospital of Zhanjiang, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Tongji Hospital, Renmin Hospital of Wuhan University, Xiangya Hospital of Central South University, Second Xiangya Hospital of 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, Changsha Third Hospital, Ankang City Central Hospital, Xijing Hospital, Tang-Du Hospital, First Affiliated Hospital Xi'an Jiaotong University, Gansu Provincial Hospital, LanZhou University, Qilu Hospital of Shandong University, Binzhou People's Hospital, Jiangxi Provincial People's Hopital, The First Affiliated Hospital of Nanchang University, Second Affiliated Hospital of Nanchang University, The Third Affiliated Hospital of Nanchang University, The Second Affiliated Hospital of Harbin Medical University, The Fourth Affiliated Hospital of Harbin Medical University, Second Affiliated Hospital of Heilongjiang University of Chinese Medicine, First People's Hospital of Shenyang, Jilin Provincial People's Hospital, Beihua University, Beijing Shijitan Hospital, Capital Medical University, Beijing Chuiyangliu Hospital, Longgang District People's Hospital of Shenzhen, Xi'an Central Hospital, Nanchang Third Hospital, First Affiliated Hospital of Harbin Medical University, First Affiliated Hospital of Heilongjiang Chinese Medicine University, Heilongjiang Provicial Hospital, First Hospital of China Medical University, No 202 hospital of PLA, The Fourth Affiliated Hospital of China Medical University, The General Hospital of Northern Theater Command, Central Hospital Affiliated to Shenyang Medical Collage, Wuhan Dongxihu District People's Hospital, 3201 Hospital, No 463 Hospital of PLA
- Study start
- Oct 2012
- Primary completion
- Dec 2021 (actual)
- Study completion
- Jun 2022 (actual)
- First posted
- 20 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 14 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cinepazide | – | –Inpatient using the cinepazide in department of neurology |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Inpatient using the cinepazide in the department of neurology in 61 hospitals in China.
Key inclusion criteria (1 listed)
- Inpatient using the cinepazide in the department of neurology
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of adverse drug reaction of cinepazide in department of neurology
Time frame: 1.5 years
4 secondary outcomes
Outcomes of the patients who experienced an adverse drug reaction of cinepazide.
Time frame: 1.5 years
The predictors of the adverse drug reaction of cinepazide
Time frame: 1.5 years
Types of the adverse drug reaction of cinepazide.
Time frame: 1.5 years
The treatment when patients experienced an adverse drug reaction of cinepazide.
Time frame: 1.5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
61 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adverse Drug Reaction and Cinepazide, run by Peking University Third Hospital at 61 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse drug reaction of cinepazide in department of neurology (time frame: 1.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.