Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    Abelacimab
Previous Study | Return to List | Next Study

Safety and Tolerability of Abelacimab (MAA868) vs. Rivaroxaban in Patients With Atrial Fibrillation (AZALEA-TIMI 71)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04755283
Recruitment Status : Recruiting
First Posted : February 16, 2021
Last Update Posted : December 2, 2021
Sponsor:
Collaborators:
The TIMI Study Group
Covance
Information provided by (Responsible Party):
Anthos Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE February 11, 2021
First Posted Date  ICMJE February 16, 2021
Last Update Posted Date December 2, 2021
Actual Study Start Date  ICMJE February 2, 2021
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2021)
Evaluate effect of abelacimab relative to rivaroxaban on the rate of major or clinically relevant non-major (CRNM) bleeding events [ Time Frame: From randomization through study completion, an average of 17 months ]
Time to first event of composite of International Society on Thrombosis and Haemostasis (ISTH)-defined major bleeding or CRNM bleeding events
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2021)
  • Evaluate effect of abelacimab relative to rivaroxaban on the rate of major bleeding events [ Time Frame: From randomization through study completion, an average of 17 months ]
    Time to first event ISTH-defined major bleeding events
  • Evaluate the effect of abelacimab relative to rivaroxaban on the rate of major or minor bleeding events [ Time Frame: From randomization through study completion, an average of 17 months ]
    Time to first event ISTH-defined major or minor bleeding events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Tolerability of Abelacimab (MAA868) vs. Rivaroxaban in Patients With Atrial Fibrillation
Official Title  ICMJE 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)
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This is an event-driven, randomized, active-controlled, blinded endpoint, parallel-group study to evaluate the effect of two blinded doses of abelacimab relative to open-label rivaroxaban on the rate of major or clinically relevant non-major (CRNM) bleeding events in patients with atrial fibrillation (AF) who are at moderate-to-high risk of stroke.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
All care providers are blinded with the exception of the pharmacist and study team member assigned to administer the subcutaneous injection of abelacimab.
Primary Purpose: Supportive Care
Condition  ICMJE
  • Atrial Fibrillation (AF)
  • Stroke
Intervention  ICMJE
  • Biological: Abelacimab
    Abelacimab provided as liquid in vial (150 mg/mL)
    Other Name: MAA868
  • Drug: Rivaroxaban
    Rivaroxaban 15 mg and 20 mg provided as commercially available film-coated tablets
Study Arms  ICMJE
  • Experimental: Abelacimab (MAA868)

    Treatment group 1: Abelacimab middle dose subcutaneous (s.c.) monthly

    Treatment group 2: Abelacimab high dose subcutaneous (s.c.) monthly

    Intervention: Biological: Abelacimab
  • 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.

    Intervention: Drug: Rivaroxaban
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 11, 2021)
1200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2023
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  • 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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Janeen Salter 1-617-430-6957 info@anthostherapeutics.com
Listed Location Countries  ICMJE Canada,   Czechia,   Hungary,   Korea, Republic of,   Poland,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04755283
Other Study ID Numbers  ICMJE ANT-006
2020-004507-13 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anthos Therapeutics, Inc.
Study Sponsor  ICMJE Anthos Therapeutics, Inc.
Collaborators  ICMJE
  • The TIMI Study Group
  • Covance
Investigators  ICMJE Not Provided
PRS Account Anthos Therapeutics, Inc.
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP