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Apixaban

Phase 2

Atrial Fibrillation | Small molecule | Cardiovascular |Unity Biotechnology, Inc.|Last Updated: Jun 22, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment151
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03987711Strategies for the Management of Atrial Fibrillation in patiEnts Receiving DialysisPHASE2 COMPLETED 151Dec 10, 2019Dec 31, 2022Jun 22, 202328 Australia, Canada
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Study Endpoints
Primary Endpoints
Recruitment of the target population within 2 years
2 years from start of trial
At least 80% of randomized participants remain in the trial and on the allocated study treatment at the end of the 26-week study period.
26 weeks
Secondary Endpoints
Proportion of patients randomized to warfarin achieving a Time in the Therapeutic Range (TTR) >65%.
26 weeks
>95% of randomized patients adhere to the enrollment criteria with respect to atrial fibrillation or atrial flutter
End of trial
Major bleeding
26 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
WarfarinEXPERIMENTALIndividuals randomized to this arm will be exposed to dose-adjusted daily warfarin targeting an international normalized ratio (INR) of 2.0-3.0.
ApixabanACTIVE_COMPARATORIndividuals randomized to this arm will receive apixaban 5 mg twice daily (a reduced dose of 2.5 mg twice daily will be given to selected participants).
No oral anticoagulationACTIVE_COMPARATORIndividuals in this arm will be exposed to a treatment strategy in which no oral anticoagulation is prescribed.
Interventions
NameTypeDescription
WarfarinDRUGIndividuals randomized to this arm will be exposed to dose-adjusted daily warfarin targeting an international normalized ratio (INR) of 2.0-3.0.
ApixabanDRUGIndividuals randomized to this arm will receive apixaban 5 mg twice daily (a reduced dose of 2.5 mg twice daily will be given to selected participants).
No oral anticoagulationOTHERNo oral anticoagulation
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites28

Inclusion Criteria: 1. Age ≥ 18 years. 2. Receiving maintenance hemodialysis or peritoneal dialysis for \> 90 days. 3. History of AF or atrial flutter as defined by: (i) AF or atrial flutter on a 12 lead ECG at enrollment, and not due to a reversible cause, or (ii) AF or atrial flutter document...

Countries:AustraliaCanada
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