LV Thrombus After Acute AMI: A Randomized Controlled Trial
Status:
Unknown status
Trial end date:
2015-06-01
Target enrollment:
Participant gender:
Summary
Left Ventricular (LV) thrombus formation is witnessed in at least 10% of patients with ST
segment elevation myocardial infarction (STEMI). It is a feared complication since it might
increase the risk of thrombo-embolic events, including 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 P2Y12 inhibitors) to prevent stent thrombosis.
Consequently, STEMI patients with LV thrombus are currently treated with triple
antithrombotic therapy (aspirin, P2Y12 inhibitors, 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.
Design: A multicenter, prospective, randomized, two non-inferiority trial. The objective of
the study is to determine in a randomized fashion the risks and benefits of the addition of
vitamin K antagonists to dual anti-platelet therapy or dual anti-platelet therapy in patients
with PCI-treated STEMI and LV thrombus formation on baseline echocardiography or baseline
Magnetic Resonance Imaging (MRI).
Phase:
N/A
Details
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)