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Andexanet Alfa for Emergency Surgery (ANNEXA-RS Trial)

Phase 3

Waitlist Available

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up screening (day -1 to day 0) until follow-up visit (day 30 or day 120)

Awards & highlights

ANNEXA-RS Trial Summary

This trial will study if a drug is safe and effective at preventing major bleeding during surgery or procedures.

Who is the study for?

This trial is for patients needing urgent surgery within 12 hours who have taken an oral FXa inhibitor like apixaban and are at high risk of bleeding. They must not be facing acute life-threatening bleeding or require heparin during surgery, nor should they have a history of certain blood disorders or hypersensitivity to andexanet alfa.Check my eligibility

What is being tested?

The study tests if andexanet alfa can safely prevent major bleeding in urgent surgeries compared to usual care. It's for those who've recently taken blood thinners and need quick reversal before their procedure.See study design

What are the potential side effects?

Potential side effects of andexanet alfa may include reactions at the injection site, possible allergic reactions, or changes in blood pressure. The exact side effects will be monitored throughout the trial.

ANNEXA-RS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to two hours post start of surgery or procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to two hours post start of surgery or procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to two hours post start of surgery or procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of patients achieving effective intraoperative hemostasis

Secondary outcome measures

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

Other outcome measures

Number of patients with adverse events

Side effects data

From 2019 Phase 2 trial • 108 Patients • NCT03310021

13%

Nasopharyngitis

13%

Foot Fracture

13%

Pharyngitis

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 4 Edoxaban 60 mg QD/High Dose Andexanet

Cohort 4 Edooxaban 60 mg QD/Placebo

Cohort 5 Apixaban 5 mg BID/Low Dose Andexanet

Cohort 5 Apixaban 5 mg BID/Placebo

Cohort 9 Rivaroxaban 15 mg BID/Placebo

Cohort 10 Edoxaban 60 mg QD /Low Dose Andexanet

Cohort 10 Edoxaban 60 mg QD/Placebo

Cohort 3 Edooxaban 60 mg QD/Placebo

Cohort 6 Apixaban 10 mg BID/Placebo

Cohort 8 Apixaban 10 mg BID/Placebo

Cohort 3 Edoxaban 60 mg QD/High Dose Andexanet

Cohort 1 Apixaban 5 mg BID/Low Dose Andexanet

Cohort 1 Apixaban 5 mg BID/Placebo

Cohort 2 Rivaroxaban15 mg BID/High Dose Andexanet

Cohort 2 Rivaroxaban 15 mg BID/Placebo

Cohort 6 Apixaban 10 mg BID/High Dose Andexanet

Cohort 7 Edoxaban 30 mg QD/Low Dose Andexanet

Cohort 7 Edoxaban 30 mg QD/Placebo

Cohort 8 Apixaban 10 mg BID/Low Dose Andexanet

Cohort 9 Rivaroxaban 15 mg BID/Low Dose Andexanet

ANNEXA-RS Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Andexanet Alfa GroupExperimental Treatment1 Intervention

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

Group II: Usual Care GroupActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Andexanet alfa

2017

Completed Phase 2

~5590

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,259 Previous Clinical Trials

288,593,102 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment accommodating geriatric patients?

"This trial demands that participants meet the prerequisites of being between 18 and 130 years old."

Answered by AI

What precautions should be taken when administering Andexanet Alfa to patients?

"The safety of Andexanet Alfa Group was assessed at a 3 due to the existence of multiple rounds of evidence proving efficacy, and prior clinical data corroborating its security."

Answered by AI

Are there multiple venues in North America where this clinical experiment is occurring?

"This clinical trial has a total of 112 sites located in Kashihara-shi, Kawasaki-shi and Kumamoto-shi as well as many other cities. It is advised to choose the nearest site available so that you can reduce travel demands if enrolled."

Answered by AI

Are there any available vacancies for participants in this experiment?

"According to information available on clinicaltrials.gov, the recruitment period for this trial has ended. Initially posted October 20th 20203 and last updated September 6th of that same year, patients are no longer able to enroll in this study; however two other trials remain open for participants at present."

Answered by AI

Is it permissible for me to be enrolled in this experiment?

"This clinical trial is recruiting 800 individuals aged 18 to 130 who are in need of emergency surgery. All participants must meet the following requirements: they should require urgent medical treatment (in the opinion of their attending physician), this operation should be performed within 12 hours after consenting, a high risk of bleeding or damage to an essential organ during surgery is likely, oral FXa inhibitors such as apixaban, rivaroxaban and edoxaban were taken over 15 hours prior to start of procedure; female patients that have not gone through menopause will need negative pregnancy test results at screening and all fertile males/females must agree"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Study of Andexanet Alfa in Patients Requiring Urgent Surgery or Procedure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05926349.