Embolism and Thrombosis Clinical Trial
Official title:
Comparison of Accidents and Their Circumstances With Oral Anticoagulants. The CACAO Study
Differences in efficacy and safety between new oral anticoagulants (NOAC) and vitamin K
antagonist (VKA) in real practice remain uncertain.
The few existing ambulatory studies did not answer all NOAC specific issues, such as
prescription habits and motives, patients characteristics, biological monitoring, as well as
the occurrence of major and minor thromboembolic events, especially in France where warfarin
is less frequently prescribed.
Therefore, in order to describe clinical and follow up characteristics of patients receiving
oral anticoagulants, the investigators will set up a national prospective cohort to compare
the occurrence of thromboembolic events between VKA and NOAC in primary care.
The method includes the use of a national prospective observational cohort, involving 444
general practitioners From april to december 2014, health data of any adult patient
consulting a general practitioner and receiving an oral anticoagulant treatment has been
entered in a database. Each patient received an information for agreement to participate to
the study (agreement for stastical analysis of their health data during one year follow up).
In March 2015, half of those patients will be chosen (stratification), using a matched
stratification process, and will be followed up over one year. Every three months, data
regarding the occurrence of therapeutics changes, episodes of excessive bleeding, and
thromboembolic events will be collected by general practitioners.
The data will be analysed by: - describing the characteristics of patients receiving oral
anticoagulant treatment; - describing the changes of medications over the year ; - comparing
the occurrence of episodes of excessive bleeding ; - comparing the occurrence of
thromboembolic events in patients using VKA versus patients using NOAC.
;
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