Linker Ventrikel Thrombus Formatie na het Acuut Myocardinfarct - een gerandomiseerde multi-center onderzoek die 2 verschillende anti-trombotische strategien vergelijkt

Left Ventricular (LV) thrombus formation is witnessed in at least 10% of
patients with ST elevation myocardial infarction (STEMI). It is a feared
complication since it might increase the risk of thrombo-embolic events,
including fatal stroke. Guidelines recommend vitamin K antagonist treatment in
these patients. However patients with STEMI nowadays undergo primary
percutaneous coronary intervention (PCI) with coronary stent placement and
consequently require dual anti-platelet therapy (ascal and clopidogrel) to
prevent stent thrombosis. Consequently, STEMI patients with LV thrombus are
currently treated with triple antithrombotic therapy (aspirin, thienopyridine
class antiplatelet agent, e.g. clopidogrel (75 mg/d) and vitamin K antagonist).
Patients treated with triple antithrombotic therapy are subject to a strongly
increased bleeding risk with a yearly incidence of 3.7% for dual anti-platelet
therapy as compared to 12% for triple antithrombotic therapy. About 10% of
these bleedings are cerebral. The mortality of such haemorrhagic strokes is
25%. A recent retrospective analysis did not show any beneficial effects of
addition of vitamin K antagonist to dual anti-platelet therapy to prevent
stroke. If vitamin K antagonist-therapy could be omitted, morbidity and
mortality due to post-PCI bleedings will decrease. Therefore, a randomized
trial is warranted to address this issue.

The objective of this study is to determine in a randomized fashion the risks
as well as the benefits of the addition of vitamin K antagonists to dual
anti-platelet therapy in patients with PCI-treated STEMI and LV thrombus
formation

A multicenter, prospective, randomized, non-inferiority trial with blinded
evaluation of endpoints

After written informed consent has been obtained, echocardiography and MRI are performed within 8 weeks after PCI. When LV thrombus is present on baseline MRI, patients are randomized to 1) Triple antithrombotic therapy (aspirin (100 mg/d), thienopyridine class antiplatelet agent, e.g. clopidogrel (75 mg/d) and vitamin K antagonist (goal INR is 2.0 to 3.0)) 2) Dual anti-platelet therapy (aspirin (100mg/d) and thienopyridine class antiplatelet agent, e.g. clopidogrel (75 mg/d).

Als door loting wordt bepaald met 3 bloedverdunners behandeld wordt dan hoger
bloedingrisico. Als door loting bepaald wordt met 2 bloedverdunners behandeld
wordt dan bestaat er mogelijk een hoger risico voor stolsels in de slagaderen
van de longen, been en hersenen.