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

NCT05926349 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: D9604C00001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study will aim to find out if the drug andexanet alfa is safe and effective in preventing major bleeding during urgent surgery or invasive procedures. The study will compare the use of andexanet alfa to the usual care given at the study center.

Conditions

Urgent Surgery

Keywords

Andexanet alfa; Blood Thinners

Outcome Measures

Primary Outcomes (1)

• Number of patients achieving effective intraoperative hemostasis

  Intraoperative hemostasis will be assessed according to the categories as per 4-point hemostasis scale: Excellent - Normal hemostasis, Good - Mildly abnormal hemostasis (eg. slight oozing from surgical wounds), Moderate - Moderate abnormality in intraprocedural hemostasis (eg. controllable bleeding), Poor - Severe hemostatic abnormality (eg. severe refractory hemorrhage). Hemostasis will be considered to be effective if the intraoperative hemostasis category is 'excellent' or 'good', and ineffective if the intraoperative hemostasis category is 'moderate' or 'poor'.

  From start to the end of surgery or procedure on Day 0

Secondary Outcomes (2)

• Change from Baseline in anti-FXa activity measured through blood samples

  Baseline to start of surgery or procedure

• Change from Baseline in anti-FXa activity measured through blood samples

  Baseline to two hours post start of surgery or procedure

Other Outcomes (1)

• Number of patients with adverse events

  Screening (Day -1 to Day 0) until follow-up visit (Day 30 or Day 120)

Study Arms (2)

Andexanet Alfa Group

EXPERIMENTAL

Patients will receive andexanet alfa as IV bolus followed by an infusion.

Drug: Andexanet alfa

Usual Care Group

ACTIVE COMPARATOR

Patients will receive treatment based on the Investigator's discretion, according to regional, local/institutional guidelines or practices.

Drug: Usual Care

Interventions

Andexanet alfa DRUG

Andexanet is a recombinant version of human FXa

Also known as: Andexxa®, Ondexxya®

Andexanet Alfa Group

Usual Care DRUG

As per the label of the chosen usual care product(s) and/or usual care standards.

Usual Care Group

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient requires, in the opinion of the Investigator, urgent surgery or procedure and requires reversal of direct oral FXa inhibition.
• The patient requires urgent surgery or procedure within 12 hours of informed consent.
• The patient requires urgent surgery or procedure that is expected to be associated with a high risk of bleeding or bleeding to occur into a critical organ.
• The patient has taken an oral FXa inhibitor (such as apixaban, rivaroxaban, or edoxaban) within 15 hours or more, prior to start of surgery or procedure.
• Female patients of childbearing potential must have a negative pregnancy test at Screening.
• Willingness to use highly effective methods of contraception (for male and female patients who are fertile).

You may not qualify if:

• The patient requires surgeries or procedures that have a very low chance of causing significant, uncontrollable bleeding, such as small skin procedures, cataract surgery, and minor dental procedures.
• The patient has acute life-threatening bleeding at the time of Screening.
• The patient will undergo a surgery or procedure which will require the use of heparin.
• Patient who is not expected to live for more than three months due to other health problems or has specifically requested not to be resuscitated if their heart stops beating.
• Prior to screening, the patient had either experienced low platelet count due to heparin use with or without blood clots or had a genetic condition that affects blood clotting.
• Patient has acute decompensated heart failure, cardiogenic shock, sepsis, or septic shock at the time of Screening.
• Patient has history of heparin-induced thrombocytopenia (with or without thrombosis) or inherited coagulopathy (eg, anti-thrombin III deficiency, anti-phospholipid antibody syndrome, protein C/S deficiency, Factor V Leiden) at the time of Screening.
• Previously diagnosed with a bleeding disorder (eg, platelet function disorder, hemophilia, Von Willebrand disease, or coagulation factor deficiency).
• Prior known hypersensitivity to andexanet alfa.
• Use of andexanet alfa 30 days prior to Screening.
• Patient diagnosed with dementia.
• Any prohibited medication as determined in the study.

Sponsors & Collaborators

• AstraZeneca: lead

MeSH Terms

Interventions

PRT064445

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: July 3, 2023
• Study Start: August 2, 2024
• Primary Completion (Estimated): January 5, 2027
• Study Completion (Estimated): September 7, 2027
• Last Updated: October 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at: https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patientlevel data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at: https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure.