Apixaban Versus Warfarin in Patients With Left Ventricular (LV) Thrombus
Status:
Completed
Trial end date:
2021-05-31
Target enrollment:
Participant gender:
Summary
Patients with acute ST-segment elevation myocardial infarction (STEMI) have an elevated risk
of stroke, most of which are cardio-embolic in origin as a result of left ventricular (LV)
thrombus formation. Anterior-wall location of a MI, in particular, can lead to the
complications of LV aneurysm and/or thrombus, which some estimate occurs in approximately up
to one-third of individuals within the first 2 weeks following an anterior MI.
In the absence of anti coagulation, the risk of embolization in patients with a documented LV
thrombus has been reported to be between 10 and 15 percent [3]. Although there are no
randomized trials evaluating the efficacy of anticoagulation in patients with an LV thrombus
after MI, observational studies provide substantial supporting evidence for the
recommendation to anticoagulate patients with documented LV thrombus in order to reduce the
risk of embolization. The observation that most events occur within the first three months
from the MI forms the basis for the recommendation that anticoagulant therapy should be
started early and continued for at least three to six months after myocardial infarction.
Currently the practice guidelines recommend anticoagulation after MI only in certain settings
such as the presence of LV thrombus or atrial fibrillation. To date there are no data on the
use of novel oral anticoagulants (NOACS) for stroke prevention in the setting of LV thrombus
after acute MI.
The proposed aim of this randomized open label non inferiority clinical trial is to assess
whether apixaban is as effective as VKA for the treatment of LV thrombus after acute ST
segment elevation MI.
Population: Patients with evidence of LV thrombus as assessed by trans-thoracic
echocardiography (TTE) 3 to 7 days post admission for acute ST-elevation MI
Intervention: The patients will be randomly assigned to treatment with apixaban or s.c
enoxaparin 1mg/Kg BID followed by dose-adjusted warfarin to achieve a target international
normalized ratio (INR) of 2.0 to 3.0 for 3 months.
The study Outcomes are the presence of LV thrombus as assessed be echo, major bleeding, and
stroke or systemic embolism and death from any cause.