Study to Evaluate the effIcacy and Safety of Abelacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral Anticoagulation

Sponsor
Novartis Pharmaceuticals
Study ID
NCT07739888
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Atrial Fibrillation (AF)

Eligibility Criteria

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

Interventions

  • Abelacimab — BIOLOGICAL
    Abelacimab provided as liquid in vial (150 mg/mL)

Study Details

This OLE part is an optional, single arm, multicenter, open-label extension (OLE) added to the core part to assess the long-term safety, tolerability, the incidence of ischemic stroke or SE and bleeding events of abelacimab in eligible patients who completed the double-blinded core part of CMAA868A2302 (ANT-010/NCT05712200)

Key Dates

First listed
Jul 31, 2026
Start date
Dec 30, 2027
Status verified
Jul 2026
Primary completion
Dec 30, 2030
Completion
Dec 30, 2030

Study Design

Enrollment
2,500 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Abelacimab (MAA868)
    abelacimab 150 mg subcutaneous (SC)

Primary Outcome Measure

Time to first ISTH major Bleeding events [ Time Frame: Up to 3 years ]

Central Contacts

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