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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Qian Tong, MD
- Numéro de téléphone: '+86-13074337289'
- E-mail: tongqian187@aliyun.com
Sauvegarde des contacts de l'étude
- Nom: Mingyou 'Zhang', MD
- Numéro de téléphone: +86-13689842200
- E-mail: zmy@jlu.edu.cn
Lieux d'étude
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Jilin
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Changchun, Jilin, Chine, 130021
- Recrutement
- First Hospital of Jilin University
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Contact:
- Qian Tong, MD
- Numéro de téléphone: +86-13074337289
- E-mail: tongqian187@aliyun.com
-
Contact:
- Mingyou Zhang, MD
- Numéro de téléphone: +86-13689842200
- E-mail: zmy@jlu.edu.cn
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
Autres noms:
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.
Autres noms:
|
|
Comparateur actif: 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.
Autres noms:
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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence of Clinically Relevant Bleeding Events
Délai: 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
|
|
Net Adverse Clinical Events (NACE)
Délai: 12 months after randomization
|
Composite of all-cause death, myocardial infarction, ischemic stroke and major bleeding. |
12 months after randomization
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies vasculaires
- Maladies cardiovasculaires
- Processus pathologiques
- Maladies cardiaques
- Artériosclérose
- Maladies artérielles occlusives
- Maladie coronarienne
- Ischémie myocardique
- Conditions pathologiques, signes et symptômes
- Maladie de l'artère coronaire
- Hémorragie
- Syndrome coronarien aigu
- Composés de soufre
- Produits chimiques organiques
- Pyridines
- Composés hétérocycliques, 1 anneau
- Composés hétérocycliques
- Composés hétérocycliques, 2 anneaux
- Composés hétérocycliques, anneau fusionné
- Acides nucléiques, nucléotides et nucléosides
- Hydrocarbures
- Hydrocarbures, cyclique
- Hydrocarbures, aromatique
- Purines
- Phénols
- Dérivés de benzène
- Nucléosides
- Ribonucléosides
- Thiophenes
- Salicylates
- Hydroxybenzoates
- Adénosine
- Nucléosides purines
- Ticlopidine
- Thiénopyridines
- Ticagrélor
- Clopidogrel
- Aspirine
Autres numéros d'identification d'étude
- ASPIRE-LD
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
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.
Informations sur les médicaments et les dispositifs, documents d'étude
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