Atrial Fibrillation Clinical Trial
Official title:
A Study Programme for the Evaluation of Oral Anticoagulation Therapy With Vitamin K Antagonists
Since decades, oral anticoagulation (OAC) with vitamin K antagonists (VKA) is an established
therapy for both prevention and treatment of thromboembolism in daily clinical routine.
Increasing life-expectancy, the demographic change and novel oral anticoagulants lead to an
increasing complexity of medical therapy. However, data on quality and management of VKA
therapy with phenprocoumon in current medical care are limited. Our aim was to investigate
the quality of OAC with VKA in current health care and to evaluate the potential for
improvements.
The investigator-initiated thrombEVAL study program comprises two cohorts of patients treated
with vitamin K antagonists for oral anticoagulation therapy in real-life settings: a
multicentre cohort of patients in regular medical care and a multi-local, single centre
cohort of patients in a telemedicine-based coagulation service. The study program is expected
to enrol a total number of approximately 2,000 to 2,500 patients. Both cohorts build on a
detailed clinical assessment of participants and anticoagulation therapy at study enrolment.
Subsequently active and passive follow-up investigations are carried out to document and
validate complications of the treatment. Primary short-term outcome is the distribution of
time in therapeutic range; the primary long-term outcome comprises the composite of stroke,
systemic embolism, myocardial infarction, major and clinically-relevant bleeding and death.
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