What side effects are associated with this type of intervention?

Common treatments for Deep Vein Thrombosis (DVT) include direct oral anticoagulants (DOACs) such as apixaban, rivaroxaban, and dabigatran, as well as low-molecular-weight heparin (LMWH) and warfarin. Known side effects of these treatments include bleeding complications, which can range from minor to major or life-threatening. DOACs are associated with a more predictable pharmacokinetic profile and lower incidence of certain complications compared to warfarin, but they still carry a risk of gastrointestinal bleeding and other bleeding events. Low-molecular-weight heparin can cause injection site reactions and, rarely, heparin-induced thrombocytopenia. Factor XI inhibitors like Abelacimab, currently under study, aim to reduce the risk of bleeding while effectively preventing clot formation.

What prior FDA approvals exist?

The FDA has approved several anticoagulants for the treatment of Deep Vein Thrombosis (DVT). These include direct oral anticoagulants (DOACs) such as apixaban, rivaroxaban, edoxaban, and dabigatran, which inhibit Factor Xa or thrombin. These drugs offer advantages like rapid onset, ease of administration, and predictable pharmacokinetics. While Abelacimab, a Factor XI inhibitor, is currently being studied, it represents a novel approach compared to the existing Factor Xa and thrombin inhibitors. The approval of these DOACs has significantly advanced the management of DVT by providing effective and convenient alternatives to traditional therapies like warfarin.

What other types of research exist?

Promising alternatives to Abelacimab for DVT treatment include Apixaban, a Factor Xa inhibitor, which has been extensively studied and shown efficacy in preventing thromboembolism. Additionally, investigational therapies such as Concizumab, an anti-TFPI antibody, and Mim8, a bispecific antibody, are also being explored for their potential in managing thrombotic conditions.

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Monoclonal Antibodies

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

Q: What is the mechanism of action of this treatment?

Common treatments for Deep Vein Thrombosis (DVT) include anticoagulants such as direct oral anticoagulants (DOACs) and emerging drugs like Abelacimab. DOACs, including rivaroxaban and apixaban, work by inhibiting Factor Xa, a key enzyme in the coagulation cascade, thereby preventing clot formation. Abelacimab, on the other hand, targets Factor XI, which plays a role in the intrinsic pathway of blood coagulation. By inhibiting Factor XI, Abelacimab aims to reduce clot formation with potentially lower bleeding risks compared to traditional anticoagulants. Understanding these mechanisms is vital for DVT patients as it helps in choosing treatments that effectively prevent clot recurrence while minimizing the risk of bleeding complications.

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

Must not have

Thrombectomy, insertion of a caval filter or use of a fibrinolytic agent to treat the current (index) DVT and/or PE

Various medical conditions including platelet count <50,000/mm3, hemodynamic instability, recent stroke or hemorrhage, brain trauma or surgery, need for high-dose aspirin or antiplatelet agents, certain types of cancer, bleeding requiring medical attention, planned major surgeries, poor performance status, limited life expectancy, impaired kidney function, low hemoglobin, liver conditions, uncontrolled hypertension, and others

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing abelacimab, a medication, to prevent blood clots in cancer patients who have had previous clots. It aims to see if it works better and causes fewer bleeding problems compared to a current treatment.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a procedure or treatment for a blood clot in my veins.

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I do not have severe medical conditions like recent major bleeding, serious heart issues, or planned major surgeries.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Deep Vein Thrombosis (DVT) include anticoagulants such as direct oral anticoagulants (DOACs) and emerging drugs like Abelacimab. DOACs, including rivaroxaban and apixaban, work by inhibiting Factor Xa, a key enzyme in the coagulation cascade, thereby preventing clot formation. Abelacimab, on the other hand, targets Factor XI, which plays a role in the intrinsic pathway of blood coagulation. By inhibiting Factor XI, Abelacimab aims to reduce clot formation with potentially lower bleeding risks compared to traditional anticoagulants. Understanding these mechanisms is vital for DVT patients as it helps in choosing treatments that effectively prevent clot recurrence while minimizing the risk of bleeding complications.

Anticoagulation in the obese patient with COVID-19-associated venous thromboembolism.Treatment of upper extremity deep vein thrombosis with apixaban and rivaroxaban.Factor XI inhibition fulfilling the optimal expectations for ideal anticoagulation.