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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

At least 1 bleeding risk factor such as severe renal insufficiency, planned daily use of antiplatelet medication for the duration of the trial, history of bleeding from a critical area, or other conditions associated with increased risk of bleeding such as chronic nonsteroidal anti-inflammatory drug (NSAID) use, frailty or multiple falls

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 months

Awards & highlights

LILAC-TIMI 76 Trial Summary

This trial studies the effect of a drug on stroke or SE risk in AF patients unable to take oral anticoagulants.

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.Check my eligibility

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.See study design

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.

LILAC-TIMI 76 Trial Eligibility Criteria

Inclusion Criteria

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

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I have a condition or take medication that increases my risk of bleeding.

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

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I or my doctor think blood thinners taken by mouth aren't right for me.

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

LILAC-TIMI 76 Trial 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

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

Primary outcome measures

Efficacy: Time to first event of ischemic stroke or systemic embolism (SE)

Safety: Time to first occurrence of Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding

Secondary outcome measures

Efficacy: All-cause mortality

Efficacy: Cardiovascular (CV) mortality

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

+2 more

LILAC-TIMI 76 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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Anthos Therapeutics, Inc.Lead Sponsor

5 Previous Clinical Trials

13,903 Total Patients Enrolled

3 Trials studying Atrial Fibrillation

11,228 Patients Enrolled for Atrial Fibrillation

Media Library

Abelacimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05712200 — Phase 3

Atrial Fibrillation Research Study Groups: Abelacimab (MAA868), Placebo

Atrial Fibrillation Clinical Trial 2023: Abelacimab Highlights & Side Effects. Trial Name: NCT05712200 — Phase 3

Abelacimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05712200 — Phase 3

Frequently Asked Questions

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

Has Abelacimab (MAA868) obtained authorization from the FDA?

"Abelacimab (MAA868) is deemed safe, with a score of 3 given the presence of efficacy-supporting data and numerous safety trials."

Answered by AI

What is the scope of recruitments for this experiment?

"Affirmative, the entry on clinicaltrials.gov states that this medical trial is in its active recruitment phase. Originally posted on December 27th 2022 and most recently updated January 25th 2023, this experiment requires approximately 1900 participants from 3 different sites."

Answered by AI

Are there any slots open for volunteers within this trial?

"Affirmative. Data located on clinicaltrials.gov demonstrates that this study, first posted on December 27th 2022, is presently accepting applicants. Approximately 1900 people need to be accepted from 3 trial locations."

Answered by AI