Abelacimab vs. Rivaroxaban for Atrial Fibrillation
(AZALEA-TIMI 71 Trial)

Recruiting in Palo Alto (17 mi)

+81 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Anthos Therapeutics, Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing a new blood thinner called abelacimab to see if it causes less bleeding compared to an existing drug, rivaroxaban. It focuses on patients with atrial fibrillation who are at a higher risk of stroke. Blood thinners help prevent strokes by stopping clots, but they can also cause bleeding.

Eligibility Criteria

This trial is for adults aged 55 or older with atrial fibrillation at moderate-to-high stroke risk, who need long-term blood thinners. They should have a CHA2DS2-VASc score of ≥4, or ≥3 with certain conditions and planned use of antiplatelet meds. People can't join if they're allergic to the study drugs, had recent serious bleeding, significant heart valve narrowing, mechanical heart valves, other anticoagulant needs like clots, or specific heart conditions.

Inclusion Criteria

I am 55 years old or older.

You have a certain score on a risk assessment tool for stroke called CHA2DS2-VASc.

My kidney function, measured by creatinine clearance, is 50 ml/min or less.

+2 more

Exclusion Criteria

I am on blood thinners for reasons other than atrial fibrillation.

I have a tumor in my heart's left chamber or a blood clot in my heart.

I have not had a brain or eye bleed in the last 3 months.

+4 more

Participant Groups

The ANT-006 study compares Abelacimab (MAA868) to Rivaroxaban in patients with atrial fibrillation to see which causes less bleeding. Patients are randomly assigned to receive either Abelacimab or Rivaroxaban as their anticoagulation therapy.

2Treatment groups

Experimental Treatment

Active Control

Group I: Abelacimab (MAA868)Experimental Treatment1 Intervention

Treatment group 1: Abelacimab middle dose subcutaneous (s.c.) monthly Treatment group 2: Abelacimab high dose subcutaneous (s.c.) monthly Extension Treatment Group: Abelacimab high dose subcutaneous (s.c.) monthly

Group II: RivaroxabanActive Control1 Intervention

Treatment group 3: Rivaroxaban 20 mg by mouth; orally (p.o.) once per day with the evening meal Patients with a Creatinine Clearance (CrCl) ≤50 ml/min by the Cockcroft-Gault equation will have a dose adaptation to rivaroxaban 15 mg p.o. daily.