ABSTRACT
In the past years several case-control studies established the association of an elevated
plasma homocysteine concentration and the risk of venous thromboembolism. It is still
unclear if elevated homocysteine concentrations can cause venous thrombosis. The VITRO
(VItamins and ThROmbosis) trial is the first multicenter, randomized, double-blind
and placebo-controlled study to evaluate the effect of homocysteine-lowering therapy
by means of 5 mg folic acid, 0.4 mg vitamin B
12 and 50 mg vitamin B6. The study is a secondary prevention trial in 600 patients who suffered from a first
episode of idiopathic deep vein thrombosis (DVT) or pulmonary embolism (PE), or both.
There will be 300 hyperhomocysteinemic and 300 normohomocysteinemic patients included,
all with an objectivated venous thrombosis. The end point is recurrence of venous
thrombosis.
KEYWORD
Homocysteine - hyperhomocysteinemia - venous thrombosis - vitamin treatment - multicenter
trial