Aspirin 50mg vs 100mg Combined With P2Y12 Inhibitor After PCI (ASPIRE-LD)
The Efficacy and Safety of Aspirin 50mg Versus 100mg in Combination With a P2Y12 Inhibitor After Percutaneous Coronary Intervention: A Randomized, Open-label, Active-controlled, Non-inferiority Trial
This is a randomized, open-label, active-controlled, non-inferiority clinical trial (the ASPIRE-LD trial) conducted in China. It aims to compare the efficacy and safety of low-dose aspirin (50 mg once daily) versus standard-dose aspirin (100 mg once daily), both in combination with a P2Y12 inhibitor, in patients who have successfully undergone percutaneous coronary intervention (PCI) and plan to receive at least 12 months of dual antiplatelet therapy (DAPT).
A total of 2640 eligible patients will be randomly assigned in a 1:1 ratio to receive either 50 mg or 100 mg of enteric-coated aspirin daily, plus a P2Y12 inhibitor (ticagrelor 90 mg twice daily or clopidogrel 75 mg once daily, prescribed according to routine clinical practice). All participants will be followed for 12 months after randomization.
The primary goal is to verify that 50 mg aspirin is non-inferior to the 100 mg standard dose in preventing major adverse cardiac and cerebrovascular events (MACCE: cardiovascular death, non-fatal myocardial infarction, definite/probable stent thrombosis, and ischemic stroke) at 12 months post-PCI. If non-inferiority is confirmed, the study will further test whether 50 mg aspirin reduces clinically relevant bleeding events (BARC type 2, 3, or 5) better than the standard dose.
The study is sponsored by the First Hospital of Jilin University and will be carried out in 10-15 tertiary hospitals across China. Its findings will provide evidence for optimizing aspirin dosing in post-PCI DAPT.
調査の概要
詳細な説明
Background Dual antiplatelet therapy (DAPT) - aspirin combined with a P2Y12 inhibitor - is the standard of care to prevent stent thrombosis and ischemic events after PCI. However, the optimal aspirin dose in combination with modern P2Y12 inhibitors remains undefined, especially in Chinese populations. Current practice widely uses 100 mg daily aspirin, but pharmacological and clinical evidence suggests that lower doses may achieve comparable antiplatelet effect with a lower bleeding risk.
Study Design This is a multicenter, randomized, open-label, active parallel-controlled non-inferiority trial. Enrollment will include 2640 adults with acute or chronic coronary syndrome who have undergone successful PCI and are scheduled for at least 12 months of DAPT. Randomization will be stratified by study center with a 1:1 allocation ratio.
Treatment Regimens
- Experimental group: enteric-coated aspirin 50 mg once daily + a P2Y12 inhibitor
- Control group: enteric-coated aspirin 100 mg once daily + a P2Y12 inhibitor The choice of P2Y12 inhibitor (ticagrelor or clopidogrel) is at the treating physician's discretion based on patient characteristics and clinical guidelines. DAPT will be maintained for a minimum of 12 months.
Outcome Assessment All suspected endpoint events will be independently adjudicated by a blinded Clinical Endpoint Committee according to standardized international definitions. A Data Monitoring Committee will periodically review safety data and study conduct.
Follow-up visits are scheduled at 1 month, 6 months, and 12 months after randomization, including clinical assessment, medication adherence evaluation, and event verification.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Qian Tong, MD
- 電話番号：'+86-13074337289'
- メール：tongqian187@aliyun.com
研究連絡先のバックアップ
- 名前：Mingyou 'Zhang', MD
- 電話番号：+86-13689842200
- メール：zmy@jlu.edu.cn
研究場所
-
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Jilin
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Changchun、Jilin、中国、130021
- 募集
- First Hospital of Jilin University
-
コンタクト：
- Qian Tong, MD
- 電話番号：+86-13074337289
- メール：tongqian187@aliyun.com
-
コンタクト：
- Mingyou Zhang, MD
- 電話番号：+86-13689842200
- メール：zmy@jlu.edu.cn
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Aged 18 to 85 years at the time of screening
- Diagnosed with acute coronary syndrome (ACS) or chronic coronary syndrome (CCS)
- Has undergone successful percutaneous coronary intervention (PCI) with stent implantation
- Planned to receive at least 12 months of dual antiplatelet therapy (DAPT) with aspirin plus a P2Y12 inhibitor after PCI
- Able to provide written informed consent and comply with study follow-up requirements
Exclusion Criteria:
- Known hypersensitivity or contraindication to aspirin, P2Y12 inhibitors, or related excipients
- High bleeding risk: history of intracranial hemorrhage, gastrointestinal bleeding within 6 months, active bleeding diathesis, or coagulopathy
- Severe hepatic dysfunction (Child-Pugh class C) or severe renal impairment (eGFR < 30 mL/min/1.73 m²)
- Ischemic or hemorrhagic stroke within 3 months before enrollment
- Pregnant or lactating women; women of childbearing potential unwilling to use effective contraception
- Life expectancy < 12 months due to other severe comorbidities such as advanced malignancy
- Participation in another interventional clinical trial within 30 days before screening
- Any other condition judged by the investigator to make the patient unsuitable for the study
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：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：Low-dose Aspirin
Participants receive enteric-coated aspirin 50 mg once daily, combined with a P2Y12 inhibitor (ticagrelor 90 mg twice daily or clopidogrel 75 mg once daily), for at least 12 months after successful percutaneous coronary intervention. |
Enteric-coated aspirin for oral administration, once daily. Two dose levels are studied: 50 mg in the experimental arm and 100 mg in the active comparator arm.
他の名前：
Background antiplatelet therapy used in both study arms. Either ticagrelor 90 mg orally twice daily or clopidogrel 75 mg orally once daily, prescribed at the treating physician's discretion according to clinical guidelines.
他の名前：
|
|
アクティブコンパレータ：Standard-dose Aspirin
Participants receive enteric-coated aspirin 100 mg once daily, combined with a P2Y12 inhibitor (ticagrelor 90 mg twice daily or clopidogrel 75 mg once daily), for at least 12 months after successful percutaneous coronary intervention. |
Enteric-coated aspirin for oral administration, once daily. Two dose levels are studied: 50 mg in the experimental arm and 100 mg in the active comparator arm.
他の名前：
Background antiplatelet therapy used in both study arms. Either ticagrelor 90 mg orally twice daily or clopidogrel 75 mg orally once daily, prescribed at the treating physician's discretion according to clinical guidelines.
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 |
|---|---|---|
|
Incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE)
時間枠：12 months after randomization
|
Composite endpoint including cardiovascular death, non-fatal myocardial infarction, definite or probable stent thrombosis, and ischemic stroke, independently adjudicated by a blinded clinical endpoint committee. |
12 months after randomization
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of Clinically Relevant Bleeding Events
時間枠：12 months after randomization
|
Bleeding events classified by the Bleeding Academic Research Consortium (BARC) criteria, including BARC grade 2, 3 and 5. |
12 months after randomization
|
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Net Adverse Clinical Events (NACE)
時間枠：12 months after randomization
|
Composite of all-cause death, myocardial infarction, ischemic stroke and major bleeding. |
12 months after randomization
|
協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- Davi G, Patrono C. Platelet activation and atherothrombosis. N Engl J Med. 2007 Dec 13;357(24):2482-94. doi: 10.1056/NEJMra071014. No abstract available.
- Patrono C, Garcia Rodriguez LA, Landolfi R, Baigent C. Low-dose aspirin for the prevention of atherothrombosis. N Engl J Med. 2005 Dec 1;353(22):2373-83. doi: 10.1056/NEJMra052717. No abstract available.
- Patrono C, Ciabattoni G, Patrignani P, Pugliese F, Filabozzi P, Catella F, Davi G, Forni L. Clinical pharmacology of platelet cyclooxygenase inhibition. Circulation. 1985 Dec;72(6):1177-84. doi: 10.1161/01.cir.72.6.1177.
研究記録日
主要日程の研究
研究開始 (実際)
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
- ASPIRE-LD
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
Individual participant data will not be shared to protect patient privacy and confidentiality. This is an investigator-initiated trial without dedicated funding and specialized resources for public data sharing. Aggregate results of the study will be published in peer-reviewed academic journals.
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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