An observational study in Coronary Heart Disease and Angina Pectoris, sponsored by China Academy of Chinese Medical Sciences. Status unknown. Per ClinicalTrials.gov, last updated 2012-06-06.
Sponsored by China Academy of Chinese Medical Sciences · Observational
This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in October 2011.
It was funded by China major scientific and technological specialized project for 'significant new formulation of new drugs'.
Kudiezi is kind of Chinese Medicine injection used for treating coronary heart disease and angina pectoris in many Chinese hospitals.
The purpose of this study is to determine adverse drug events or adverse drug reaction in large sample size 30,000 patients.
It is very common that Chinese Medicine Injection used in hospitals in mainland China. However safety problems rose in recent years. There could be many uncertain factors influence Chinese Medicine Injection in clinical practice.
Safety surveillance on Chinese Medicine injection is an important problem that needs to be sorted out through large sample observational study.
A registry study for Kudiezi injection safety surveillance with 30000 patients will be conducted from Jan.2012 to Dec.2015.
Eligibility criteria Patients who will use Kudiezi injection in selected hospitals
Data will be collected in four aspects by four different forms as following:
Form A (blue): demographic information Form B (yellow): adverse drug events/reaction Form C (white): extracted information from hospital information system and laboratory information system Form D (red): personalized information
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's planned enrollment of 30,000 is above the median of 294 across 1,241 observational studies indexed under Heart Diseases.
Browse Heart Diseases studies →China Academy of Chinese Medical Sciences is the lead sponsor of 61 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
An anticipated sample size was caculated in this study, about 30000. Patients using Kudiezi injection from 2012 to 2014 in more than 20 hospitals.
Exclusion Criteria:
Number of participants with adverse events; incidence of Kudiezi'ADRs and identify factors that contributed to the occurrence of the adverse reaction
All patients will be measured and assessed at the time Kudiezi is administered to them until they discharge. Patients using Kudiezi will be registered on a registration form including disease background, Kudiezi's administration, and extraction information from hospital information system. An adverse event or drug adverse reaction form also will be used to describe any doubted symptoms or signs from patients. A judgment will be made by doctors directly and a further analysis will be conducted by researchers to decide those potential side effects of Kudiezi.
Time frame: to assess Kudiezi's 'adverse event' and 'drug adverse reaction' during patients' hospital stay, administration information of Kudiezi will be registered every day. The registry procedure will last 3 years only for patients using Kudiezi.
No study locations are listed for this record.
This study is status unknown, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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China Academy of Chinese Medical Sciences