What side effects are associated with this type of intervention?

Common treatments for Atrial Fibrillation (AF) include anticoagulants, antiarrhythmic drugs, and cardioversion. Anticoagulants, such as warfarin and direct oral anticoagulants (DOACs), can cause bleeding complications, including life-threatening hemorrhages. Antiarrhythmic drugs, like amiodarone and sotalol, may lead to side effects such as thyroid dysfunction, pulmonary toxicity, and proarrhythmia. Cardioversion, both electrical and pharmacologic, can cause arrhythmias, skin burns (in electrical cardioversion), and adverse reactions to medications used in pharmacologic cardioversion.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Atrial Fibrillation, primarily focusing on anticoagulation and rhythm control. For anticoagulation, direct oral anticoagulants (DOACs) such as dabigatran, rivaroxaban, and apixaban have been approved to reduce the risk of stroke and systemic embolism in patients with AF. Warfarin, a vitamin K antagonist, has also been a long-standing option. For rhythm control, antiarrhythmic drugs like amiodarone, flecainide, and sotalol are commonly used. While Factor XI inhibitors like Abelacimab are still under investigation, they represent a novel approach to anticoagulation that may offer benefits in reducing thromboembolic events with potentially lower bleeding risks.

What other types of research exist?

Promising novel alternatives to Abelacimab for Atrial Fibrillation patients include: 1) Factor Xa inhibitors such as Rivaroxaban and Apixaban, which are well-established but continue to see new formulations and delivery methods. 2) Direct thrombin inhibitors like Dabigatran, which offer a different mechanism of action. 3) Investigational agents like Asundexian, another Factor XI inhibitor, which is currently in clinical trials and shows potential for reducing bleeding risks while preventing thromboembolic events.

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Monoclonal Antibodies

Abelacimab for Atrial Fibrillation (LILAC-TIMI 76 Trial)

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

Diagnosed Atrial Fibrillation (AF) or atrial flutter (documented on an electrocardiogram (ECG) or monitor recording)

Age 65-74 and a CHA2DS2VASc ≥5 OR age ≥75 and a CHA2DS2VASc ≥4

Must not have

Mechanical heart valve or valve disease that is expected to require mechanical valve replacement intervention (surgical or invasive) during the course of the study

Patients with an intracranial or intraocular bleed within the 3 months prior to screening or any history of spontaneous intracerebral hemorrhage at any time in the absence of antithrombotic treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 months

Awards & highlights

Pivotal Trial

Summary

This trial is testing abelacimab, a medication aimed at preventing strokes and blood clots in people with Atrial Fibrillation. These patients are either unsuitable for or have chosen not to use common medications for thinning blood. Abelacimab works by reducing the blood's ability to form dangerous clots.

Who is the study for?

This trial is for adults with Atrial Fibrillation who can't take oral anticoagulants. Participants must be 65-74 years old with a high stroke risk score or at least 75 with a slightly lower score, and have at least one bleeding risk factor. People who've had recent serious bleeds or strokes, AF from reversible causes, or used certain blood thinners recently cannot join.

What is being tested?

The study tests abelacimab against a placebo to see if it lowers the chance of stroke or clots in patients unsuitable for standard blood thinner pills. It's designed to compare how well each treatment prevents these events without causing harmful side effects.

What are the potential side effects?

While specific side effects of abelacimab are not listed here, similar medications may cause bleeding risks, injection site reactions, and potentially allergic responses. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with Atrial Fibrillation or flutter confirmed by an ECG.

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I am 65-74 with a high stroke risk score or 75+ with a moderate stroke risk score.

Exclusion Criteria

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

Select...

I have a mechanical heart valve or need one due to my valve disease.

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I have not had a brain or eye bleed in the last 3 months or any brain bleed without blood thinner treatment.

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I have taken blood thinners like warfarin or dabigatran in the last 2 months.

Select...

I have not had a stroke or mini-stroke shortly before joining the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Efficacy: Time to first event of ischemic stroke, systemic embolism (SE), myocardial infarctions (MI), venous thromboembolism (VTE), or acute limb ischemia

Time to first event of ischemic stroke, systemic embolism (SE), myocardial infarctions (MI), venous thromboembolism (VTE), acute limb ischemia, or International Society on Thrombosis and Haemostasis (ISTH) major bleeding

Awards & Highlights

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Abelacimab (MAA868)Experimental Treatment1 Intervention

Patients will be randomized in a 1:1 ratio to receive abelacimab 150 mg subcutaneous (SC) or matching placebo once monthly.

Group II: PlaceboPlacebo Group1 Intervention

Patients will be randomized in a 1:1 ratio to receive abelacimab 150 mg subcutaneous (SC) or matching placebo once monthly.

0 / 6Eligibility 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

The most common treatments for Atrial Fibrillation (AF) include rate control medications (e.g., beta-blockers, calcium channel blockers), rhythm control medications (e.g., antiarrhythmic drugs like amiodarone, sotalol), and anticoagulants to prevent thromboembolism (e.g., warfarin, direct oral anticoagulants). Rate control medications work by slowing the heart rate, making AF more manageable. Rhythm control medications aim to restore and maintain a normal heart rhythm. Anticoagulants prevent blood clots that can lead to stroke. Factor XI inhibitors, such as abelacimab, represent a novel approach by targeting a specific part of the coagulation cascade, potentially reducing the risk of stroke with fewer bleeding complications. This is particularly important for AF patients who are at high risk of stroke but may be unsuitable for traditional anticoagulants due to bleeding risks.

Pharmacologic management of atrial fibrillation: established and emerging options.