Atrial Fibrillation Clinical Trial
Official title:
Prospective Randomized Trial of a Clinical Algorithm to Predict the Loading Dose of Phenprocoumon
Oral anticoagulation is often initiated in hospitalized patients. Although the therapeutic
range of phenprocoumon is narrow, the individual drug demands unfortunately vary greatly
between persons. Our group recently developed two dosing algorithms for the initiation of
anticoagulation based on clinical predictors such as age, gender, body weight and laboratory
values.
The aim of the proposed study is to prospectively evaluate the efficacy and safety of these
two algorithms in medical and orthopedic inpatients, as well as in a group of outpatients
and possibly in a geriatric collective.
Background:
The presently available oral anticoagulants have a very narrow therapeutic range but the
interindividual demands to achieve therapeutic anticoagulation (=loading dose) varies
greatly. Overanticoagulation is a major cause of bleeding complications, whereas
insufficient anticoagulation is associated with thromboembolic disease and possibly
prolonged hospital stay. A model to predict the loading dose with phenprocoumon (Marcoumar®)
is therefore highly desirable.
In a retrospective analysis of 300 inpatients (152 medical, 148 orthopedic patients) of the
Cantonal Hospital of St. Gallen our group identified clinical predictors for the loading
dose of phenprocoumon and two dosing algorithms were developed (Good AC, Henz S. A clinical
algorithm to predict the loading dose of phenprocoumon. Thromb Res. 2007;120(6):921-5.).
In order to validate the safety and efficacy of these dosing algorithms we plan this
prospective interventional study with three equally sized arms: dosing according to
algorithm 1, dosing according to algorithm 2 or dosing according to the estimate of the
physician (control).
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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