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

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
Anthos Therapeutics, Inc.
Study ID
NCT04755283
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Atrial Fibrillation (AF)
  • Stroke

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Abelacimab — BIOLOGICAL
    Abelacimab provided as liquid in vial (150 mg/mL)
  • Rivaroxaban — DRUG
    Rivaroxaban 15 mg and 20 mg provided as commercially available film-coated tablets

Study Details

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.

Key Dates

Start date
Feb 2, 2021
Status verified
Oct 2025
Primary completion
Feb 15, 2024
Completion
Dec 29, 2028

Study Design

Enrollment
1,287 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Abelacimab 90 mg (MAA868)
    Treatment group 1: Abelacimab low dose subcutaneous (s.c.) monthly Extension Treatment Group: Abelacimab high dose subcutaneous (s.c.) monthly
  • Experimental: Abelacimab 150 mg (MAA868)
    Treatment group 2: Abelacimab high dose subcutaneous (s.c.) monthly Extension Treatment Group: Abelacimab high dose subcutaneous (s.c.) monthly
  • Active Comparator: Rivaroxaban
    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.

Primary Outcome Measure

Incidence Rate of the First Occurrence of Composite of International Society on Thrombosis and Haemostasis (ISTH)-Defined Major Bleeding or Clinically Relevant Non-Major (CRNM) Bleeding Events [ Time Frame: Assessed at every visit from randomization through the end of the randomized phase of the study, up to 33 months. ]

Locations (28)

FacilityCityStateZIPSite coordinators
Anthos Investigative SiteHuntsvilleAlabama35801-
Anthos Investigative SiteMobileAlabama36608-
Anthos Investigative SiteStamfordConnecticut06905-
Anthos Investigative SiteClearwaterFlorida33756-
Anthos Investigative SiteDaytona BeachFlorida32114-2321-
Anthos Investigative SiteLargoFlorida33777-
Anthos Investigative SiteSafety HarborFlorida34695-
Anthos Investigative SiteSaint AugustineFlorida32086-
Anthos Investigative SiteJohns CreekGeorgia30024-
Anthos Investigative SiteOwensboroKentucky42303-
Anthos Investigative SiteBaltimoreMaryland21229-5222-
Anthos Investigative SiteSalisburyMaryland21804-
Anthos Investigative SiteFraminghamMassachusetts01701-
Anthos Investigative SiteHaverhillMassachusetts01830-
Anthos Investigative SiteLansingMichigan48912-
Anthos Investigative SiteSewellNew Jersey08080-
Anthos Investigative SitePoughkeepsieNew York12601-
Anthos Investigative SiteSouthamptonNew York11968-
Anthos Investigative SiteLenoirNorth Carolina28645-
Anthos Investigative SiteFargoNorth Dakota58104-
Anthos Investigative SiteOklahoma CityOklahoma73135-
Anthos Investigative SiteCamp HillPennsylvania17011-
Anthos Investigative SiteKingsportTennessee37660-
Anthos Investigative SiteKingwoodTexas77339-
Anthos Investigative SiteOdessaTexas79761-5133-
Anthos Investigative SiteTomballTexas77375-
Anthos Investigative SiteFalls ChurchVirginia22042-
Anthos Investigative SiteManassasVirginia20109-

Find similar trials in Huntsville, AL

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Anthos Investigative Site· Huntsville, ALAnthos Investigative Site· Mobile, ALAnthos Investigative Site· Stamford, CTAnthos Investigative Site· Clearwater, FLAnthos Investigative Site· Daytona Beach, FLAnthos Investigative Site· Largo, FL

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