Drug

Apixaban

Apixaban is a direct oral anticoagulant (factor Xa inhibitor) used in atrial fibrillation and venous thromboembolism.

Sources: FDA label · 20 registered trials · 4 guideline recommendations

Apixaban at a glance

Direct Oral Anticoagulants

Mechanism: factor Xa inhibitor · FDA label (DailyMed)

Guideline:Class I · LOE AAtrial fibrillation (as a class)Boxed warning:Premature discontinuation of Eliquis increases the risk of thrombotic events; Spinal/epidural hematoma

FDA-approved indications

To reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation.
For the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in adult patients who have undergone hip or knee replacement surgery.

Show all 6

For the treatment of adults with pulmonary embolism (PE).
To reduce the risk of recurrent deep vein thrombosis (DVT) and pulmonary embolism (PE) in adult patients following initial therapy.
For the treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in pediatric patients from birth and older after at least 5 days of initial anticoagulant treatment.

Guideline position

Atrial fibrillation

Class I · LOE A2024 ESC Atrial FibrillationClass-level: names Direct Oral Anticoagulants, not apixaban
Direct oral anticoagulants are recommended in preference to VKAs to prevent ischaemic stroke and thromboembolism, except in patients with mechanical heart valves or moderate-to-severe mitral stenosis.
Class I · LOE A2024 ESC Atrial FibrillationClass-level: names Direct Oral Anticoagulants, not apixaban
Direct oral anticoagulants are recommended in preference to VKAs in eligible patients with AF undergoing cardioversion for thromboembolic risk reduction.
Class I · LOE A2024 ESC Atrial FibrillationClass-level: names Direct Oral Anticoagulants, not apixaban
For combinations with antiplatelet therapy, a DOAC is recommended in eligible patients in preference to a VKA to mitigate bleeding risk and prevent thromboembolism.
Class I · LOE A2024 ESC Atrial FibrillationClass-level: names Direct Oral Anticoagulants, not apixaban
Early cessation (≤1 week) of aspirin and continuation of an oral anticoagulant (preferably DOAC) with a P2Y12 inhibitor (preferably clopidogrel) for up to 12 months is recommended in AF patients with ACS undergoing an uncomplicated PCI to avoid major bleeding, if the risk of thrombosis is low or bleeding risk is high.

4 recommendations name a dose and are left to the guideline.

Overview

Unverified · drafted by AI from the sources cited below

Definition

Apixaban is an oral factor Xa inhibitor and direct oral anticoagulant.1 It is also a cytochrome P450 3A (CYP3A) substrate commonly used as an anticoagulant in perioperative and postoperative settings.2

Treatment

In patients with cirrhosis and portal vein thrombosis (PVT), apixaban is increasingly used and has been evaluated against rivaroxaban in a retrospective cohort study of 312 matched patients (206 apixaban, 106 rivaroxaban).1 Compared to rivaroxaban, apixaban demonstrated similar effectiveness for the composite outcome of hepatic decompensation or recurrent PVT (hazard ratio 1.01, 95% confidence interval 0.50-2.06) and a possible lower risk of gastrointestinal or intracranial bleeding (hazard ratio 0.62, 95% confidence interval 0.19-2.12), though the confidence interval crossed 1.1 Apixaban is also used in patients transitioning to oral anticoagulation prior to discharge after receiving systemic alteplase for initial management of pulmonary embolism, and its use prior to kidney transplantation is rising.23 In drug interaction evaluations, an observational hospital cohort study of 77 patients taking apixaban with or without concomitant levetiracetam for at least 72 hours found no apparent differences in minimum and maximum apixaban concentrations relative to apixaban alone, supporting the absence of a labeled warning for coadministration.5 Additionally, physiologically based pharmacokinetic modeling predicts that co-administration with the weak-to-moderate CYP3A inducer suzetrigine decreases apixaban AUCinf by 6.1% (90% confidence interval: 5.7% to 6.4%) and Cmax by 1.8% (90% confidence interval: 1.7% to 1.9%), which is not expected to represent a clinically relevant drug-drug interaction.6

Open questions

Furthermore, optimal perioperative management for patients taking apixaban prior to kidney transplantation remains uncertain, specifically regarding the necessity of preoperative reversal with four-factor prothrombin complex concentrate (4F-PCC) to balance surgical-bed bleeding risks against potential thrombotic consequences.2

Landmark trials

Primary results of 2 trials behind the evidence on apixaban, as each trial’s own publication reports them.

Left of the line at 1 favours the intervention; square size tracks trial size.Favours the interventionNo significant differenceFavours the comparator

0.250.512

ARISTOTLE
apixaban vs warfarin · 18,201 patients · N Engl J Med 2011
In patients with atrial fibrillation and at least one additional risk factor for stroke
Primary outcome: ischemic or hemorrhagic stroke or systemic embolism
HR 0.79 (0.66–0.95)
AVERROES
apixaban vs aspirin · 5,599 patients · N Engl J Med 2011
In patients with atrial fibrillation who were at increased risk for stroke and for whom vitamin K antagonist therapy was unsuitable
Primary outcome: the occurrence of stroke or systemic embolism
HR 0.45 (0.32–0.62)

Results are quoted from each trial’s primary publication abstract (PubMed); the trial name links to the paper. Ratios below 1 favour the intervention.

Trials by indication

Registered trials with apixaban in an arm, past phase 1 with at least 50 participants: the largest in each indication, newest first. Trials that give it only as the comparator are tagged; trials that give it in every arm are listed last.

Atrial fibrillation4 of 11

ROXI-EVERESTComparator arm
A Phase 3, Randomized, Multicenter, Double-blind Study to Assess Stroke and Systemic Embolism Prevention With REGN7508, a Monoclonal Antibody Against Factor XI, Versus Apixaban in Participants With Atrial Fibrillation (ROXI-EVEREST)
NCT07626411 · Phase 3 · Recruiting · 15,364 participants · started 2026
A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Active-Controlled Study to Evaluate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, Versus Apixaban in Participants With Atrial FibrillationComparator arm
NCT05757869 · Phase 3 · Active not recruiting · 20,284 participants · started 2023
OCEANIC-AFComparator arm
A Study to Learn How Well the Study Treatment Asundexian Works and How Safe it is Compared to Apixaban to Prevent Stroke or Systemic Embolism in People With Irregular and Often Rapid Heartbeat (Atrial Fibrillation), and at Risk for Stroke
NCT05643573 · Phase 3 · Terminated · 14,830 participants · started 2022
ARISTOTLE
Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation
NCT00412984 · Phase 3 · Completed · 20,976 participants · started 2006

Venous thromboembolism4 of 6

ROXI-APEXComparator arm
A Phase 3, Multicenter, Randomized, Open-Label, Study to Evaluate REGN7508, A Factor XI Monoclonal Antibody, Versus Apixaban and Enoxaparin for Prophylaxis of Venous Thromboembolism After Elective Total Knee Arthroplasty (ROXI-APEX)
NCT07015905 · Phase 3 · Recruiting · 2,000 participants · started 2025
A Multicenter, Randomized, Open-label, Blinded Endpoint Evaluation, Phase 3 Study Comparing the Effect of Abelacimab Relative to Apixaban on Venous Thromboembolism (VTE) Recurrence and Bleeding in Patients With Cancer Associated VTEComparator arm
NCT05171049 · Phase 3 · Terminated · 1,150 participants · started 2022
Randomized Trial of Rivaroxaban (Xarelto) and Apixaban (Eliquis) for the Prevention of Endothermal Heat-Induced Thrombosis (EHIT) and Deep Vein Thrombosis After Great Saphenous Vein Endovenous Laser Ablation

Chronic kidney disease

Effect of Perioperative and Short-Term Apixaban Therapy on Arteriovenous Fistula Maturation in Patients With End-Stage Renal Disease: A Randomized Controlled Trial
NCT07559942 · Recruiting · 190 participants · started 2026

Other trials

Apixaban vs. Warfarin in Left Ventricular Thrombus: A Randomized, Noninferiority Trial
NCT07709780 · Phase 3 · Recruiting · 218 participants · started 2026
Intravenous Thrombolytic Therapy in Acute Ischemic Stroke Patients on Direct Oral Anticoagulants - A Prospective Multicenter Study
NCT06241677 · Recruiting · 260 participants · started 2024

Source: ClinicalTrials.gov registry records.

How this page is built

A clinical question appears here only when its condition matches this topic, an outcome and a comparator were extracted from the studies, at least two studies and a patient count are on file, and the certainty is low or higher.

Supports benefit, no benefit shown, and mixed describe the direction of the measured effect. No benefit shown means the evidence does not support a benefit. It is not a finding of harm. Too little evidence means the question did not clear that bar.

Study count, RCT count, and patient count are separate. The patient total adds only studies that are linked into a study family and whose sample size is not flagged as implausible. A reversal is listed only when at least one randomized trial sits on each side of the change.

The overview is drafted from the guideline recommendations, trials, papers, and questions on this page, and every sentence has to cite one of them. It stays unverified until an NPI-verified clinician or a Synapse admin approves it. Approving records that person's name.

Apixaban

Apixaban at a glance

Overview

Definition

Treatment

Open questions

Landmark trials

Trials by indication

Safety and label changes

Other Direct Oral Anticoagulants

New research on Apixaban

How this page is built

Leading authors