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Published on: February 28, 2012
Apixaban vs. warfarin in patients with left ventricular thrombus: a prospective multicentre randomized clinical
Ronny Alcalai1, Adi Butnaru2, Gil Moravsky3
1Department of Cardiology, Hadassah Medical Center and Faculty of Medicine, Hebrew University of Jerusalem, PO Box 24035, Jerusalem 9124001, Israel.
Insights
Apixaban is as effective as warfarin in treating left ventricular thrombus after myocardial infarction. This study found apixaban to be non-inferior to warfarin, with fewer bleeding events observed in the apixaban group.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Current guidelines recommend vitamin K antagonists for left ventricular (LV) thrombus post-myocardial infarction (MI).
- Limited data exist on direct oral anticoagulants (DOACs) for this indication.
- Assessing novel anticoagulants is crucial for optimizing patient care after MI.
Purpose of the Study:
- To compare the efficacy and safety of apixaban versus warfarin in treating LV thrombus after acute MI.
- To evaluate the resolution rate of LV thrombus and key adverse events.
- To determine if apixaban is non-inferior to warfarin in this patient population.
Main Methods:
- A prospective, randomized, multicentre open-label trial.
- 35 patients with LV thrombus post-MI were randomized to warfarin (17) or apixaban (18).
- Primary outcome: LV thrombus presence/size at 3 months; Secondary outcomes: bleeding, stroke, mortality.
Main Results:
- Thrombus resolution occurred in 14/15 warfarin patients and 16/17 apixaban patients (non-inferiority P=0.026).
- No significant difference in thrombus size reduction between groups.
- Major bleeding occurred in 2 warfarin patients; none in the apixaban group. One stroke in warfarin group; one death in apixaban group.
Conclusions:
- Apixaban demonstrated non-inferiority to warfarin for LV thrombus treatment post-MI.
- Apixaban showed a favorable safety profile with no major bleeding events.
- These findings support apixaban as a potential alternative to warfarin in this clinical setting.
Aims:
Current guidelines recommend anticoagulation with a vitamin K antagonist to treat left ventricular (LV) thrombus after myocardial infarction (MI). Data on the use of direct oral anticoagulants (DOACs) in this setting are limited. The aim of the study was to assess the efficacy of apixaban vs. warfarin in treating LV thrombus after MI.
Methods And Results:
We conducted a prospective, randomized, multicentre open-label clinical trial including patients with LV thrombus detected by 2D transthoracic echocardiography 1-14 days after acute MI. Thirty-five patients were enrolled in three medical centres; 17 patients were randomized to warfarin and 18 patients to apixaban. The primary outcome was the presence and size of LV thrombus 3 months after initiation of anticoagulation. Secondary outcomes were major bleeding, stroke or systemic embolism, re-hospitalization, and all-cause mortality. Mean LV thrombus size at enrolment was 18.5 mm × 12.3 mm in the warfarin group and 19.9 mm × 12.4 mm in the apixaban group (P = NS). Thirty-two patients completed 3 months follow-up. In the warfarin group, two patients withdrew, and in the apixaban group one patient died. Thrombus completely resolved in 14 of 15 patients in the warfarin group and in 16 of 17 patients in the apixaban group (P = NS and P = 0.026 for non-inferiority). Two patients had major bleeding in the warfarin group, while no major bleeding events were recorded in the apixaban group. There was one stroke in the warfarin group and one death in the apixaban group.
Conclusion:
Our results suggest that apixaban is non-inferior to warfarin for treatment of patients with LV thrombus after acute MI with a 20% non-inferiority margin.
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