Safety and Tolerability of Abelacimab (MAA868) vs. Rivaroxaban in Patients With Atrial Fibrillation

Stroke Clinical Trial

— AZALEA-TIMI 71  

Official title:

A Multicenter, RandomiZed, Active-ControLled Study to Evaluate the Safety and Tolerability of Two Blinded Doses of Abelacimab (MAA868) Compared With Open-Label Rivaroxaban in Patients With Atrial Fibrillation (AZALEA)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04755283
• Other study ID #: ANT-006
• Secondary ID: 2020-004507-13
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: February 2, 2021
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: Anthos Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the ANT-006 study is to evaluate the bleeding profile of abelacimab relative to rivaroxaban in patients with atrial fibrillation (AF) at moderate-to-high risk of stroke.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1200
• Est. completion date: December 2025
• Est. primary completion date: December 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• Male and female patients = 55 years old
• Patients with a history of atrial fibrillation (AF) or atrial flutter with planned indefinite anticoagulation
• Patients with a CHA2DS2-VASc of =4 OR a CHA2DS2-VASc of =3 with at least 1 of the

following:

1. Planned concomitant use of antiplatelet medication use (i.e., aspirin and/or P2Y12 inhibitor) for the duration of the trial

2. Creatinine Clearance (CrCl) =50 ml/min by the Cockcroft-Gault equation

Exclusion Criteria:

• History of hypersensitivity to any of the study drugs (including rivaroxaban) or its excipients, to drugs of similar chemical classes, or any contraindication listed in the label for rivaroxaban
• Patients with an intracranial or intraocular bleed within the 3 months prior to screening
• Clinically significant mitral stenosis (valve area <1.5 cm2)
• Mechanical heart valve or other indication for anticoagulation therapy other than atrial fibrillation (e.g., venous thromboembolism)
• Known presence of an atrial myxoma or left ventricular thrombus
• History of left atrial appendage closure or removal
• Active endocarditis Other protocol defined Inclusion/Exclusion criteria may apply

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation (AF)
• Stroke

Intervention

Biological:
• Abelacimab
Abelacimab provided as liquid in vial (150 mg/mL)

Drug:
• Rivaroxaban
Rivaroxaban 15 mg and 20 mg provided as commercially available film-coated tablets

Locations

Country	Name	City	State
Canada	Anthos Investigative Site	Cambridge	Ontario
Canada	Anthos Investigative Site	Greenfield Park	Quebec
Canada	Anthos Investigative Site	Oshawa	Ontario
Czechia	Anthos Investigative Site	Brandýs Nad Labem	Stredoceský Kraj
Czechia	Anthos Investigative Site	Ceská Lípa	LI
Czechia	Anthos Investigative Site	Holešov	Zlín
Czechia	Anthos Investigative Site	Kromeríž	ZL
Czechia	Anthos Investigative Site	Liberec	LB
Czechia	Anthos Investigative Site	Liberec	LI
Czechia	Anthos Investigative Site	Mariánské Lázne	KA
Czechia	Anthos Investigative Site	Pardubice	PA
Czechia	Anthos Investigative Site	Podebrady	Stredoceský Kraj
Czechia	Anthos Investigative Site	Praha	PR
Czechia	Anthos Investigative Site	Praha	PR
Czechia	Anthos Investigative Site	Praha	PR
Czechia	Anthos Investigative Site	Príbram	Stredoceský Kraj
Czechia	Anthos Investigative Site	Slaný	Stredoceský Kraj
Czechia	Anthos Investigative Site	Trutnov	KR
Hungary	Anthos Investigative Site	Baja	BK
Hungary	Anthos Investigative Site	Balatonfüred	VE
Hungary	Anthos Investigative Site	Balatonfüred	VM
Hungary	Anthos Investigative Site	Budapest	BP
Hungary	Anthos Investigative Site	Budapest	BP
Hungary	Anthos Investigative Site	Budapest	BU
Hungary	Anthos Investigative Site	Debrecen	HB
Hungary	Anthos Investigative Site	Kaposvár	SO
Hungary	Anthos Investigative Site (4002)	Nyíregyháza	SZ
Hungary	Anthos Investigative Site (4003)	Nyíregyháza	SZ
Hungary	Anthos Investigative Site	Orosháza	BE
Hungary	Anthos Investigative Site	Székesfehérvár	FE
Korea, Republic of	Anthos Investigative Site	Seongnam-si	Gyeonggi
Korea, Republic of	Anthos Investigative Site	Seongnam-si	Gyeonggi
Korea, Republic of	Anthos Investigative Site	Seoul
Korea, Republic of	Anthos Investigative Site	Seoul
Poland	Anthos Investigative Site	Bielsko-Biala	SL
Poland	Anthos Investigative Site	Chrzanów	MA
Poland	Anthos Investigative Site	Dabrowa Górnicza	SL
Poland	Anthos Investigative Site	Elblag	WN
Poland	Anthos Investigative Site	Gdynia	PM
Poland	Anthos Investigative Site	Gdynia	GDY
Poland	Anthos Investigative Site	Kraków	MA
Poland	Anthos Investigative Site	Lódz	LD
Poland	Anthos Investigative Site	Lublin	LU
Poland	Anthos Investigative Site	Plock	MZ
Poland	Anthos Investigative Site	Przemysl	PK
Poland	Anthos Investigative Site	Ruda Slaska	SL
Poland	Anthos Investigative Site	Tychy	SL
Poland	Anthos Investigative Site	Warsaw	MZ
Poland	Anthos Investigative Site	Warszawa	MZ
Poland	Anthos Investigative Site	Wroclaw	DS
Poland	Anthos Investigative Site	Zamosc	LB
Poland	Anthos Investigative Site	Zarów	DS
Taiwan	Anthos Investigative Site	Hualien City	HUA
Taiwan	Anthos Investigative Site	Kaohsiung	KHH
Taiwan	Anthos Investigative Site	Taipei	TPE
Taiwan	Anthos Investigative Site	Taipei	HSZ
Taiwan	Anthos Investigative Site	Taipei City	TPE
Taiwan	Anthos Investigative Site	Tiachung	TXG
Taiwan	Anthos Investigative Site	Yilan	ILA
United States	Anthos Investigative Site	Baltimore	Maryland
United States	Anthos Investigative Site	Camp Hill	Pennsylvania
United States	Anthos Investigative Site	Clearwater	Florida
United States	Anthos Investigative Site	Falls Church	Virginia
United States	Anthos Investigative Site	Fargo	North Dakota
United States	Anthos Investigative Site	Framingham	Massachusetts
United States	Anthos Investigative Site	Haverhill	Massachusetts
United States	Anthos Investigative Site	Johns Creek	Georgia
United States	Anthos Investigative Site	Kingsport	Tennessee
United States	Anthos Investigative Site	Kingwood	Texas
United States	Anthos Investigative Site	Lansing	Michigan
United States	Anthos Investigative Site	Largo	Florida
United States	Anthos Investigative Site	Lenoir	North Carolina
United States	Anthos Investigative Site	Manassas	Virginia
United States	Anthos Investigative Site	Mobile	Alabama
United States	Anthos Investigative Site	Odessa	Texas
United States	Anthos Investigative Site	Oklahoma City	Oklahoma
United States	Anthos Investigative Site	Poughkeepsie	New York
United States	Anthos Investigative Site	Safety Harbor	Florida
United States	Anthos Investigative Site	Saint Augustine	Florida
United States	Anthos Investigative Site	Salisbury	Maryland
United States	Anthos Investigative Site	Sewell	New Jersey
United States	Anthos Investigative Site	Southampton	New York
United States	Anthos Investigative Site	Stamford	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
Anthos Therapeutics, Inc.	Fortrea, The TIMI Study Group

Countries where clinical trial is conducted

United States,  Canada,  Czechia,  Hungary,  Korea, Republic of,  Poland,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate effect of abelacimab relative to rivaroxaban on the rate of major or clinically relevant non-major (CRNM) bleeding events	Time to first event of composite of International Society on Thrombosis and Haemostasis (ISTH)-defined major bleeding or CRNM bleeding events	From randomization through study completion, an average of 17 months
Secondary	Evaluate effect of abelacimab relative to rivaroxaban on the rate of major bleeding events	Time to first event ISTH-defined major bleeding events	From randomization through study completion, an average of 17 months
Secondary	Evaluate the effect of abelacimab relative to rivaroxaban on the rate of major or minor bleeding events	Time to first event ISTH-defined major or minor bleeding events	From randomization through study completion, an average of 17 months