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)
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: Anthos Therapeutics a Novartis Company
- 전화번호: 1-888-669-6682
- 이메일: novartis.email@novartis.com
참여기준
자격 기준
공부할 수 있는 나이
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Abelacimab (MAA868)
abelacimab 150 mg subcutaneous (SC)
|
유리병에 액체로 제공되는 아벨라시맙(150mg/mL)
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Time to first ISTH major Bleeding events
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Up to 3 years
|
Up to 3 years
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Time to first event of ischemic stroke or SE
기간: 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
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- ANT-010_OLE
- 2023-503224-66-00 (기타 식별자: EU Trial (CTIS) Number)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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