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

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 Products containing cinepazide have been withdrawn in 1990s by the manufacturers because of lacking of demonstrated efficacy and the risk of agranulocytosis in some European countries, such as France, Spain,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

Official Title
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Post-Marketing Surveillance of the Cinepazide Maleate Injection: a Real World Study

Conditions
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Adverse Drug Reaction, Cinepazide, Stroke

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inpatient using the cinepazide in the department of neurology Exclusion Criteria: none
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cinepazide<br>Inpatient using the cinepazide in department of neurology | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse drug reaction of cinepazide in department of neurology |  | 1.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcomes of the patients who experienced an adverse drug reaction of cinepazide. | Outcomes including cure, improved, null, or death. | 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. | 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. | 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. | 1.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cinepazide, Adverse Drug Reaction, Safety, Real World Study