Apixaban

Overview

Apixaban is an oral, direct, and highly selective factor Xa (FXa) inhibitor of both free and bound FXa, as well as prothrombinase, independent of antithrombin III for the prevention and treatment of thromboembolic diseases. It is marketed under the name Eliquis. Apixaban was approved by the FDA on December 28, 2012.

Indication

Apixaban is indicated for reducing the risk of stroke and systemic embolism in patients who have nonvalvular atrial fibrillation, prophylaxis of deep vein thrombosis(DVT) leading to pulmonary embolism(PE) in patients after a hip or knee replacement surgery, and treatment of DVT and PE to reduce the risk of recurrence.

Associated Conditions

Deep Vein Thrombosis
Deep vein thrombosis recurrent
Pulmonary Embolism
Recurrent Pulmonary Embolism (Disorder)
Stroke
Systemic Embolism

Clinical Trials

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Title	Posted	Study ID	Phase	Status	Sponsor
Anticoagulation in ICH Survivors for Stroke Prevention and Recovery	2019/04/08	NCT03907046	Phase 3	Recruiting	Yale University
Study to Learn More About the Benefits and Side-effects of Drugs Rivaroxaban and Apixaban Compared to the Drug Warfarin for Stroke Prevention in Patients With Rapid and Irregular Heartbeat Which is Not Due to a Heart-valve Fault (Non-valvular Atrial Fibrillation) in the UK Routine Clinical Practice	2019/02/20	NCT03847181	N/A	Completed	Bayer
Trial of Apixaban vs Warfarin in Reducing Rate of Cognitive Decline, Silent Cerebral Infarcts and Cerebral Microbleeds in Patients With Atrial Fibrillation	2019/02/15	NCT03839355	Phase 3	Terminated	Mayo Clinic
A Nationwide Observational Study Looking at Effectiveness and Bleeding Complications of NOACs vs. VKA in Non-valvular Atrial Fibrillation Patients.	2018/10/23	NCT03715725	N/A	Terminated	Bayer
API-CAT STUDY for APIxaban Cancer Associated Thrombosis	2018/10/02	NCT03692065	Phase 3	Completed	Assistance Publique - Hôpitaux de Paris
Apixaban for Extended Anticoagulation (APIDULCIS)	2018/09/19	NCT03678506	Phase 4	Terminated	Arianna Anticoagulazione Foundation
Efficacy and Safety of Apixaban in the Treatment of Heparin Induced Thrombocytopenia (HIT)	2018/07/20	NCT03594045	Phase 2	Terminated	Massachusetts General Hospital
Calf Deep Vein Thrombosis Treatment Trial	2018/07/18	NCT03590743	Phase 4	Terminated	Mayo Clinic
Non-interventional, Retrospective Cohort Study to Explore OAC Treatment in Korea	2018/06/28	NCT03572972	N/A	Completed	Pfizer
Direct Oral Anticoagulants in Patients With Atrial Fibrillation (DOACs vs DOACs)	2018/06/26	NCT03568916	N/A	Completed	Canadian Network for Observational Drug Effect Studies, CNODES

FDA Drug Approvals

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Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

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Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

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Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

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Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

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Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
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