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

Официальное название

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)

Обзор

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)

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Time to first ISTH major Bleeding events [Срок оценки: Up to 3 years]
• Time to first BARC type 3c/5 bleeding [Срок оценки: Up to 3 years]
• Number of participants with ISTH major or CRNM bleeding [Срок оценки: Up to 3 years]
• Number of participants with bleeding [Срок оценки: Up to 3 years]
• Number of participants with TEAEs and TESAEs [Срок оценки: Up to 3 years]
• Number of participants with treatment discontinuations due to TEAEs [Срок оценки: Up to 3 years]
• Number of participants with device related AEs, SAEs, and device deficiencies [Срок оценки: Up to 3 years]

Вторичные конечные точки (1)

• Time to first event of ischemic stroke or SE [Срок оценки: Up to 3 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07739888 · ANT-010_OLE · 2023-503224-66-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗