STudy of Aspirin Removal in Patients Supported by the Fully Magnetically Levitated CH-VAD Pump (STAR)
A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled STudy of Aspirin Removal in Patients Supported by the Fully Magnetically Levitated CH-VAD Pump (STAR Trial)
調査の概要
状態
条件
詳細な説明
研究の種類
入学 (推定)
段階
- フェーズ 4
連絡先と場所
研究連絡先
- 名前:Kai Chen, Dr
- 電話番号:13269333241
- メール:ck_2003@126.com
研究連絡先のバックアップ
- 名前:Zelin Yin
- 電話番号:13321153733
- メール:zelin_0823@163.com
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
-
Study participants must meet all the following criteria:
- Age ≥18 years old;
- Implanted with the CH-VAD pump for advanced heart failure, and the CH-VAD pump is the first implanted left ventricular assist device;
- Able to understand the study purpose, voluntarily participate and sign the informed consent form, and willing to comply with the study procedures and follow-up requirements.
Exclusion Criteria:
-
Study participants meet any of the following criteria will be excluded:
- Requirement for additional temporary or permanent mechanical circulatory support after LVAD implantation;
- Requirement for physician-mandated antiplatelet therapy after implantation due to medical history, surgical history, concomitant surgical procedures, or other conditions, including mandated presence or absence of antiplatelet agent;
- Occurrence of primary endpoint events prior to randomization (within 2-7 days after implantation);
- Inability to take oral medications post-implant through 7 days;
- Known allergy to aspirin;
- Participation in another clinical investigation that may affect study outcome;
- Presence of other comorbid conditions, social or psychological conditions, or other conditions, in the investigator's opinion, that may affect participation in the study or compliance with follow-up requirements.
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:ランダム化
- 介入モデル:並列代入
- マスキング:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Placebo group
vitamin K antagonist with placebo
|
Warfarin (INR 2-3) with placebo
|
|
アクティブコンパレータ:Aspirin group
vitamin K antagonist with aspirin
|
Warfarin (INR 2-3) with aspirin
|
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 |
|---|---|---|
|
Survival free from major hemocompatibility-related adverse events at 12 months post-implantation
時間枠:12 months post implantation
|
Major hemocompatibility-related adverse events include stroke, suspected or confirmed pump thrombosis, peripheral arterial embolism, myocardial infarction, aortic root thrombosis, and non-surgical major bleeding. Note: Stroke includes ischemic stroke and hemorrhagic stroke. Non-surgical major bleeding is defined as major bleeding events occurring more than 14 days after implantation, including Type 3-5 bleeding events and intracranial hemorrhage that does not meet the definition of hemorrhagic stroke. |
12 months post implantation
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Key Secondary Outcome: Incidence of major thromboembolic events at 12 months post-implantation
時間枠:12 months post implantation
|
Major thromboembolic events include ischemic stroke, suspected or confirmed pump thrombosis, peripheral arterial embolism, myocardial infarction, and aortic root thrombosis.
|
12 months post implantation
|
|
Incidence of non-surgical bleeding
時間枠:12 months post implantation
|
including non-surgical major bleeding and hemorrhagic stroke
|
12 months post implantation
|
|
Overall survival rate
時間枠:12 months post implantation
|
Overall survival rate
|
12 months post implantation
|
|
Incidence of stroke
時間枠:12 months post implantation
|
Including all stroke, hemorrhagic stroke, ischemic stroke, and disabling stroke
|
12 months post implantation
|
|
Incidence of pump thrombosis
時間枠:12 months post implantation
|
Including suspected pump thrombosis
|
12 months post implantation
|
|
Incidence of peripheral arterial embolism
時間枠:12 months post implantation
|
Incidence of peripheral arterial embolism
|
12 months post implantation
|
|
Incidence of myocardial infarction
時間枠:12 months post implantation
|
Incidence of myocardial infarction
|
12 months post implantation
|
|
Incidence of aortic root thrombosis
時間枠:12 months post implantation
|
Incidence of aortic root thrombosis
|
12 months post implantation
|
|
Incidence of bleeding
時間枠:12 months post implantation
|
Including major bleeding, gastrointestinal bleeding, and hemorrhagic stroke
|
12 months post implantation
|
|
Rehospitalization rate
時間枠:12 months post implantation
|
Rehospitalization rate
|
12 months post implantation
|
|
Hemocompatibility score
時間枠:12 months post implantation
|
To determine the aggregate net burden of HRAE in each patient, a tiered hierarchal score (hemocompatibility score [HCS]) that weights each event by its escalating clinical relevance was calculated for each patient as previously described.
(Mehra MR.
The burden of haemocompatibility with left ventricular assist systems: a complex weave.
Eur Heart J 2017.
doi: https:// doi.org/10.1093/eurheartj/ehx036.)
In brief, mild events contributed a single point to the HCS, whereas serious events contributed a higher grade to the HCS.
The HCS was calculated for each patient by summing up all the points associated with each HRAE experienced by the patient for the duration of available follow-up.
The HCS served as the net burden of all HRAEs experienced by the patient for the duration of 12-month follow-up.
|
12 months post implantation
|
|
Change in NYHA functional class from baseline
時間枠:12 months post implantation
|
Change in NYHA functional class from baseline
|
12 months post implantation
|
|
Change in EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Index Score from baseline
時間枠:12 months post implantation
|
Change in EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Index Score from baseline
|
12 months post implantation
|
|
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score from baseline
時間枠:12 months post implantation
|
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score from baseline
|
12 months post implantation
|
|
Change in exercise capacity (6-minute walk test) from baseline
時間枠:12 months post implantation
|
Change in exercise capacity (6-minute walk test) from baseline
|
12 months post implantation
|
協力者と研究者
協力者
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
追加の関連 MeSH 用語
その他の研究ID番号
- 2026-3116
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?
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
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