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Monoclonal Antibodies

Abelacimab vs Apixaban for Cancer-Related Blood Clots (ASTER Trial)

Q: For what medical ailments is Abelacimab commonly prescribed?

<p>Abelacimab can help patients with <a href="https://www.withpower.com/clinical-trials/atrial-fibrillation">atrial fibrillation</a>, deep vein thrombosis, and disease.</p>

Phase 3

Recruiting

Research Sponsored by Anthos Therapeutics, Inc.

Eligibility Criteria Checklist

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

Must have

Confirmed symptomatic or incidental proximal lower limb deep vein thrombosis (DVT) or pulmonary embolism (PE)

Anticoagulation therapy with a therapeutic dose of DOAC for at least 6 months is indicated

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

ASTER Trial Summary

This trial will compare the effect of two different drugs on preventing blood clots and bleeding in cancer patients.

Who is the study for?

Adults diagnosed with cancer-associated venous thromboembolism (VTE), including deep vein thrombosis or pulmonary embolism, can join this trial if they've been diagnosed within the past 120 hours and need blood thinners for at least 6 months. They must not have used certain treatments for VTE, have specific medical conditions, or be on conflicting medications.Check my eligibility

What is being tested?

The study is testing Abelacimab against Apixaban to see which is better at preventing VTE from coming back and causing less bleeding in patients with cancer-related VTE. It's a Phase 3 trial where participants are randomly chosen to receive one of the two drugs.See study design

What are the potential side effects?

Potential side effects may include bleeding complications due to the blood-thinning nature of both Abelacimab and Apixaban. The exact side effects will vary between individuals based on their condition and response to treatment.

ASTER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a blood clot in my leg or lungs.

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I have been on a blood thinner medication for at least 6 months.

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I have been diagnosed with cancer (excluding basal or squamous skin cancer) and am currently receiving or have received cancer treatment in the last 6 months.

ASTER Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Time to first event of centrally adjudicated VTE recurrence consisting of new proximal deep venous thrombosis, new pulmonary embolism (PE) or fatal PE, including unexplained death for which PE cannot be ruled out

Secondary outcome measures

Net clinical benefit defined as survival without VTE recurrence, or major or CRNM bleeding

Time to first event of ISTH-adjudicated major or clinically relevant non-major (CRNM) bleeding events

Side effects data

From 2018 Phase 4 trial • 557 Patients • NCT01884337

Incision site pain

100%

80%

60%

40%

20%

Study treatment Arm

TOTAL KNEE REPLACEMENT (TKR)

TOTAL HIP REPLACEMENT (THR)

ASTER Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: AbelacimabExperimental Treatment1 Intervention

Abelacimab intravenous administration followed by monthly administration of the same dose subcutaneously

Group II: ApixabanActive Control1 Intervention

Apixaban administered orally twice a day

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

ItreasUNKNOWN

1 Previous Clinical Trials

1,020 Total Patients Enrolled

1 Trials studying Deep Vein Thrombosis

1,020 Patients Enrolled for Deep Vein Thrombosis

Anthos Therapeutics, Inc.Lead Sponsor

5 Previous Clinical Trials

14,148 Total Patients Enrolled

1 Trials studying Deep Vein Thrombosis

1,020 Patients Enrolled for Deep Vein Thrombosis

Media Library

Abelacimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05171049 — Phase 3

Deep Vein Thrombosis Research Study Groups: Abelacimab, Apixaban

Deep Vein Thrombosis Clinical Trial 2023: Abelacimab Highlights & Side Effects. Trial Name: NCT05171049 — Phase 3

Abelacimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05171049 — Phase 3

Frequently Asked Questions

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

Abelacimab has been linked to what sorts of adverse health effects?

"Abelacimab has received a score of 3 from our team at Power, as it is a Phase 3 trial drug. This means that while there is some data supporting efficacy, multiple rounds of data support safety."

Answered by AI

Does the medical literature contain other research on Abelacimab?

"Abelacimab was first researched in 2015 at Hospital Juan Ramon Jimenez. So far, there have been 122 completed studies and 52 ongoing ones. The majority of the live studies are being conducted in Hamilton, Ontario."

Answered by AI

How many individuals are being recruited for this experiment?

"In order to run this clinical trial smoothly, 1655 eligible patients are required. The locations of Hamilton Health Sciences, Juravinski Hospital and Cancer Centre in Hamilton, Ontario as well as University of Miami Health in Miami, Florida allow for easy patient participation."

Answered by AI

For what medical ailments is Abelacimab commonly prescribed?

"Abelacimab can help patients with atrial fibrillation, deep vein thrombosis, and disease."

Answered by AI

Has this clinical trial been conducted before?

"Abelacimab has been the subject of medical research since 2015, when it was first trialled by Pfizer. The successful Phase 4 trial involved 4012 patients. As of today, 52 studies are ongoing in 454 cities and 36 countries."

Answered by AI

Are we still enrolling people for this experiment?

"That is correct. The listing on clinicaltrials.gov currently states that the trial is admitting 1655 participants at 16 locations. The trial was originally posted on 5/5/2022 and was most recently updated on 11/10/2022."

Answered by AI

Is this clinical trial prevalent in the United States?

"This trial is being conducted at several locations, including Hamilton Health Sciences in Hamilton, Juravinski Hospital and Cancer Centre in Ontario, University of Miami Health in Florida, Queen Elizabeth II Health Sciences Centre in Nova Scotia, District of Columbia."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study Comparing Abelacimab to Apixaban in the Treatment of Cancer-associated VTE

2022. "A Study Comparing Abelacimab to Apixaban in the Treatment of Cancer-associated VTE". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05171049.

All > Pulmonary Embolism > Apixaban