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

Phase 3Not Yet RecruitingNCT07739888

Novartis Pharmaceuticals2,500 enrolled

Overview

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)

Patients who provide consent, will need to complete the end of treatment visit (EoT) assessments of the Core Part of CMAA868A2302 (ANT-010/NCT05712200) prior to receiving first dose in the OLE. Day 1 visit or dosing should occur on same day as EoT visit to avoid treatment interruption. Participation in OLE will end if a patient permanently discontinues study treatment, or the study is completed or terminated by the Sponsor. All patients will need to complete End of Study in Extension visit in person followed by a phone call visit 30 days after End of Extension visit. Any updates in AE or concomitant medications will be reported by a phone call/video call visit.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

2,500

Conditions

Atrial Fibrillation (AF)

Interventions

AbelacimabBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients are able to provide written informed consent to enter the extension part. * Patients must be on study treatment at the time of EoT visit in the core part. Exclusion Criteria: * Patients meeting any exclusion criteria in the core part. * Patients who have a history or evidence of any clinically significant disorder, condition, or disease that in the investigator's opinion or Sponsor physician (if consulted), would put the participant at risk or interfere with the study participation * History of hypersensitivity to the study drug or its excipients, to drugs of similar chemical classes * Any medical or psychiatric condition which in the judgment of the Investigator either requires urgent medical intervention/hospitalization or may preclude patients from complying with study requirements for the duration of the study. Other protocol defined Inclusion/Exclusion criteria may apply

Outcomes

Primary Outcomes

Time to first ISTH major Bleeding events

Time to first International Society on Thrombosis and Haemostasis (ISTH) major bleeding events

Time frame: Up to 3 years

Time to first BARC type 3c/5 bleeding

Time to first Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding

Time frame: Up to 3 years

Number of participants with ISTH major or CRNM bleeding

Number of participants with International Society on Thrombosis and Haemostasis (ISTH) major or clinically relevant non-major (CRNM) bleeding

Time frame: Up to 3 years

Number of participants with bleeding

All suspected bleeding events either reported by the patient or observed by the Investigator

Time frame: Up to 3 years

Number of participants with TEAEs and TESAEs

Number of participants with treatment emergent AEs (TEAEs) and treatment emergent SAEs (TESAEs)

Time frame: Up to 3 years

Number of participants with treatment discontinuations due to TEAEs

Number of participants with treatment discontinuations due to treatment emergent AEs (TEAEs)

Time frame: Up to 3 years

Number of participants with device related AEs, SAEs, and device deficiencies

Time frame: Up to 3 years

Secondary Outcomes

Time to first event of ischemic stroke or SE

Time to first event of ischemic stroke or systemic embolism (SE). Undetermined strokes will be counted as ischemic strokes

Central Contacts

Anthos Therapeutics a Novartis Company

CONTACT

1-888-669-6682 novartis.email@novartis.com

Data from ClinicalTrials.gov

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