Andexanet alfa

DRUG8 trials

Conditions

Acute Intracranial HemorrhageAnticoagulant-related Major BleedBleedingHealthy ParticipantsHemorrhageSurgeryUrgent SurgeryVenous thromboembolism

Phase 1

A Study to Investigate Andexanet Dosing and the Interaction Between Andexanet and Subsequent Enoxaparin in Healthy Participants

RecruitingNCT07312851

AstraZenecaHealthy Participants

Start: 2026-01-19End: 2026-06-19Target: 186Updated: 2026-02-24

Phase 2

A Healthy Volunteer Pharmacokinetics (PK)/Pharmacodynamics (PD), Safety and Tolerability Study of Andexanet in Healthy Japanese and Caucasian Subjects

CompletedNCT03310021

Portola PharmaceuticalsBleeding

Start: 2017-08-28End: 2019-08-13Updated: 2023-02-24

Trial of Andexanet in Patients Receiving an Oral FXa Inhibitor Who Require Urgent Surgery

TerminatedNCT04233073

Alexion Pharmaceuticals, Inc.Surgery

Start: 2021-06-27End: 2022-01-25Updated: 2023-03-22

Phase 3

A Study of Andexanet Alfa in Patients Requiring Urgent Surgery or Procedure

WithdrawnNCT05926349

AstraZenecaUrgent Surgery

Start: 2024-08-02End: 2027-09-07Updated: 2024-10-26

Phase 4

Trial of Andexanet Alfa in ICrH Patients Receiving an Oral FXa Inhibitor

CompletedNCT03661528

Alexion Pharmaceuticals, Inc.Acute Intracranial Hemorrhage

Start: 2019-06-06End: 2023-08-09Updated: 2024-07-03

DISTINCT: inDividual, targeted thrombosIS prophylaxis versus the standard ‘one size fits all’ approach in patients undergoing Total hIp or total kNee replaCemenT: a national, multicenter, randomized, multi-arm, open-label trial

RecruitingCTIS2023-510186-98-00

Academisch Ziekenhuis LeidenVenous thromboembolism

Start: 2024-10-23Target: 10078Updated: 2025-11-14

Unknown Phase

Andexanet Alfa and 4F-PCC Use in Patients Hospitalised With an Anticoagulant-related Major Bleed

CompletedNCT05548777

AstraZenecaAnticoagulant-related Major Bleed

Start: 2022-09-15End: 2022-12-20Updated: 2023-11-28

Retrospective Study on Characteristics and Outcomes in Hospitalised Patients Treated With Ondexxya

CompletedNCT05898412

AstraZenecaHemorrhage

Start: 2023-10-06End: 2025-11-25Updated: 2026-02-06

Stroke2025-04-28

Management of factor Xa inhibitor-related traumatic non-intracranial bleeding events with andexanet alfa or four-factor prothrombin complex concentrate in a US multicenter observational study.

2024-11-071 citations

Andexanet for Factor Xa Inhibitor–Associated Acute Intracerebral Hemorrhage

New England Journal of Medicine2024-05-15193 citations

Lower mortality with andexanet alfa vs 4-factor prothrombin complex concentrate for factor Xa inhibitor-related major bleeding in a U.S. hospital-based observational study.

2023-08-3022 citations

Tranexamic Acid for Intracerebral Hemorrhage in Patients on Non-Vitamin K Antagonist Oral Anticoagulants (TICH-NOAC): A Multicenter, Randomized, Placebo-Controlled, Phase 2 Trial

Stroke2023-07-1934 citations

Andexanet alfa versus four-factor prothrombin complex concentrate for the reversal of apixaban- or rivaroxaban-associated intracranial hemorrhage: a propensity score-overlap weighted analysis

Critical Care2022-06-1664 citations

Hemostatic Efficacy and Anti-FXa (Factor Xa) Reversal With Andexanet Alfa in Intracranial Hemorrhage: ANNEXA-4 Substudy

Stroke2021-05-1062 citations