NCT01946919

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18,260

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2012

Longer than P75 for all trials

Geographic Reach
1 country

61 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2013

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

July 27, 2022

Status Verified

July 1, 2022

Enrollment Period

9.2 years

First QC Date

September 12, 2013

Last Update Submit

July 26, 2022

Conditions

Keywords

CinepazideAdverse Drug ReactionSafetyReal World Study

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse drug reaction of cinepazide in department of neurology

    1.5 years

Secondary Outcomes (4)

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

    1.5 years

  • The predictors of the adverse drug reaction of cinepazide

    1.5 years

  • Types of the adverse drug reaction of cinepazide.

    1.5 years

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

    1.5 years

Study Arms (1)

cinepazide

Inpatient using the cinepazide in department of neurology

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Inpatient using the cinepazide in the department of neurology

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (61)

China Rehabilitation Research Center

Beijing, Beijing Municipality, 100000, China

Location

Dongfang Hospital,the second clinical medical College of Beijing University of Chinese Medicine(BUCM)

Beijing, Beijing Municipality, 100000, China

Location

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine

Beijing, Beijing Municipality, 100005, China

Location

Fu Xing Hospital,Capital Medical University

Beijing, Beijing Municipality, 100009, China

Location

Beijing Chuiyangliu Hospital(Beijing Minimally Invasive Hospital)

Beijing, Beijing Municipality, 100011, China

Location

Hua Xin Hospital; First Hospital of Tsing Hua University

Beijing, Beijing Municipality, 100011, China

Location

Xuanwu Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

Beijing Shijitan Hospital,the 9th Clinical Medical College of Peking university

Beijing, Beijing Municipality, 100191, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Gansu Provincial Hospital

Lanzhou, Gansu, 730000, China

Location

The First Affiliated Hospital of Lanzhou University

Lanzhou, Gansu, 730000, China

Location

Central People's Hospital of Zhanjiang

Ganjiang, Guangdong, 524000, China

Location

The People's Hospital of Gaozhou

Gaozhou, Guangdong, 525200, China

Location

GuangZhou First People's Hospital

Guangzhou, Guangdong, 510000, China

Location

Panyu Hospital of Chinese Medicine

Guangzhou, Guangdong, 510000, China

Location

Sun Yat-Sen Memorial Hospital Sun Yat-Sen University

Guangzhou, Guangdong, 510000, China

Location

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

Location

ZhuJiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510000, China

Location

Shantou Central Hospital Affiliated Shantou Hospital of Sun Yan-Sen University

Shantou, Guangdong, 510000, China

Location

The Second Affiliated Hospital of Shantou University Medical College

Shantou, Guangdong, 515000, China

Location

Hospital of Traditional Chinese Medicine of Zhongshan

Zhongshan, Guangdong, 528400, China

Location

People's Hospital of Dongxihu District

Wuhan, Hebei, 430040, China

Location

Shenlong Hospital

Wuhan, Hebei, 430050, China

Location

People's Hospital of Heilongjiang Province

Harbin, Heilongjiang, 150000, China

Location

The 2nd Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150000, China

Location

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150000, China

Location

The First Affiliated Hospital of Heilongjiang University Of Chinese Medicine

Harbin, Heilongjiang, 150000, China

Location

The first hospital of Harbin City

Harbin, Heilongjiang, 150000, China

Location

The Fourth Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150000, China

Location

The Second Affiliated of Heilongjiang University of Chinese Medicine

Harbin, Heilongjiang, 150000, China

Location

Renmin Hospital of Wuhan

Wuhan, Hubei, 430000, China

Location

Tongji Hospital

Wuhan, Hubei, 430000, China

Location

Wuhan Union Hospital

Wuhan, Hubei, 430000, China

Location

Hunan Provincial People's Hospital

Changsha, Hunan, 410000, China

Location

The First Hospital of Changsha

Changsha, Hunan, 410000, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

Location

The Third Hospital of Changsha

Changsha, Hunan, 410000, China

Location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

Location

Xiangya Hospital Central-South University

Changsha, Hunan, 410000, China

Location

Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, 330000, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330000, China

Location

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330000, China

Location

The Third Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330000, China

Location

The Third Hospital of Nanchang

Nanchang, Jiangxi, 330000, China

Location

Jilin Province People's Hospital

Changchun, Jilin, 130000, China

Location

Affiliated Hospital of Beihua University

Jilin, Jilin, 132000, China

Location

General Hospital of Shenyang military area command of Chinese PLA

Shenyang, Liaoning, 110000, China

Location

Shenyang First People's Hospital

Shenyang, Liaoning, 110000, China

Location

Shenzhou Hospital to Shenyang Medical College

Shenyang, Liaoning, 110000, China

Location

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110000, China

Location

The four six three hospital of people's Liberation Army

Shenyang, Liaoning, 110000, China

Location

The Fourth Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110000, China

Location

The people's Liberation Army 202nd hospital

Shenyang, Liaoning, 110000, China

Location

Ankang City Central Hospital

Ankang, Shaanxi, 725000, China

Location

San Er Ling Yi Hospital

Hanzhong, Shaanxi, 723000, China

Location

First Affiliated Hospital of Medical College of Xian Jiaotong University

Xi'an, Shaanxi, 710000, China

Location

Tangdu Hospital

Xi'an, Shaanxi, 710000, China

Location

The Central Hospital of Xi'an

Xi'an, Shaanxi, 710000, China

Location

Xijing Hospital

Xi'an, Shaanxi, 710000, China

Location

Binzhou People's Hospital

Binzhou, Shandong, 256600, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, 250000, China

Location

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse ReactionsStroke

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
14 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Suodi ZHAI, Department of Pharmacy, Peking University Third Hospital

Study Record Dates

First Submitted

September 12, 2013

First Posted

September 20, 2013

Study Start

October 1, 2012

Primary Completion

December 1, 2021

Study Completion

June 1, 2022

Last Updated

July 27, 2022

Record last verified: 2022-07

Locations