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)
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：Anthos Therapeutics a Novartis Company
- 電話番号：1-888-669-6682
- メール：novartis.email@novartis.com
参加基準
適格基準
就学可能な年齢
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Abelacimab (MAA868)
abelacimab 150 mg subcutaneous (SC)
|
アベラシマブはバイアル中の液体として提供されます (150 mg/mL)
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time to first ISTH major Bleeding events
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Up to 3 years
|
Up to 3 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time to first event of ischemic stroke or SE
時間枠：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
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- ANT-010_OLE
- 2023-503224-66-00 (その他の識別子：EU Trial (CTIS) Number)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。