Study to Evaluate the effIcacy and Safety of Abelacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral Anticoagulation (LILAC-TIMI 76)
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to evaLuate the effIcacy and Safety of abeLacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral antiCoagulation (LILAC-TIMI 76)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 3
Kontakter og lokationer
Studiekontakt
- Navn: Anthos Therapeutics a Novartis Company
- Telefonnummer: 1-888-669-6682
- E-mail: novartis.email@novartis.com
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Abelacimab (MAA868)
abelacimab 150 mg subcutaneous (SC)
|
Abelacimab leveres som væske i hætteglas (150 mg/ml)
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Time to first ISTH major Bleeding events
Tidsramme: Up to 3 years
|
Time to first International Society on Thrombosis and Haemostasis (ISTH) major bleeding events
|
Up to 3 years
|
|
Time to first BARC type 3c/5 bleeding
Tidsramme: Up to 3 years
|
Time to first Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding
|
Up to 3 years
|
|
Number of participants with ISTH major or CRNM bleeding
Tidsramme: Up to 3 years
|
Number of participants with International Society on Thrombosis and Haemostasis (ISTH) major or clinically relevant non-major (CRNM) bleeding
|
Up to 3 years
|
|
Number of participants with bleeding
Tidsramme: Up to 3 years
|
All suspected bleeding events either reported by the patient or observed by the Investigator
|
Up to 3 years
|
|
Number of participants with TEAEs and TESAEs
Tidsramme: Up to 3 years
|
Number of participants with treatment emergent AEs (TEAEs) and treatment emergent SAEs (TESAEs)
|
Up to 3 years
|
|
Number of participants with treatment discontinuations due to TEAEs
Tidsramme: Up to 3 years
|
Number of participants with treatment discontinuations due to treatment emergent AEs (TEAEs)
|
Up to 3 years
|
|
Number of participants with device related AEs, SAEs, and device deficiencies
Tidsramme: Up to 3 years
|
Up to 3 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Time to first event of ischemic stroke or SE
Tidsramme: Up to 3 years
|
Time to first event of ischemic stroke or systemic embolism (SE).
Undetermined strokes will be counted as ischemic strokes
|
Up to 3 years
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ANT-010_OLE
- 2023-503224-66-00 (Anden identifikator: EU Trial (CTIS) Number)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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