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

Recruiting

Phase N/A Results N/A

Trial Description

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 Products containing cinepazide have been withdrawn in 1990s by the manufacturers because of lacking of demonstrated efficacy and the risk of agranulocytosis in some European countries, such as France, Spain,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

Conditions

Interventions

  • Cinepazide Drug
    ARM 1: Kind: Experimental
    Label: cinepazide
    Description: Inpatient using the cinepazide in department of neurology

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial Population

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Incidence of adverse drug reaction of cinepazide in department of neurology 1.5 years Yes
Secondary Outcomes of the patients who experienced an adverse drug reaction of cinepazide. 1.5 years Yes
Secondary The predictors of the adverse drug reaction of cinepazide 1.5 years Yes
Secondary Types of the adverse drug reaction of cinepazide. 1.5 years Yes
Secondary The treatment when patients experienced an adverse drug reaction of cinepazide. 1.5 years Yes

Sponsors