Aspirin 50mg vs 100mg Combined With P2Y12 Inhibitor After PCI

NCT07846462 | Recruiting DMC

• 1 other identifier: ASPIRE-LD
• Study Type: interventional
• Target: 2,640
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease; Acute Coronary Syndromes; Chronic Coronary Syndrome; Percutaneous Coronary Intervention

Keywords

Aspirin; Dual Antiplatelet Therapy (DAPT); Percutaneous Coronary Intervention (PCI); Low-dose Aspirin; P2Y12 Inhibitor; Major Adverse Cardiac and Cerebrovascular Events; Bleeding

Outcome Measures

Primary Outcomes (1)

• Incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE)

  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

Secondary Outcomes (2)

• Incidence of Clinically Relevant Bleeding Events

  12 months after randomization

• Net Adverse Clinical Events (NACE)

  12 months after randomization

Study Arms (2)

Low-dose Aspirin

EXPERIMENTAL

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.

Drug: Aspirin; Drug: P2Y12 inhibitor

Standard-dose Aspirin

ACTIVE COMPARATOR

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.

Drug: Aspirin; Drug: P2Y12 inhibitor

Interventions

Aspirin DRUG

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.

Also known as: Acetylsalicylic Acid

Low-dose Aspirin; Standard-dose Aspirin

P2Y12 inhibitor DRUG

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.

Also known as: Ticagrelor, Clopidogrel

Low-dose Aspirin; Standard-dose Aspirin

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jilin University: lead

Study Sites (1)

First Hospital of Jilin University

Changchun, Jilin, 130021, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 3933848 BACKGROUND

• 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.

  PMID: 16319386 BACKGROUND

• 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.

  PMID: 18077812 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Acute Coronary Syndrome; Hemorrhage

Interventions

Aspirin; Ticagrelor; Clopidogrel

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Qian Tong, MD

CONTACT

'+86-13074337289'; tongqian187@aliyun.com

Mingyou 'Zhang', MD

CONTACT

+86-13689842200; zmy@jlu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Although the trial is open-label for participants and treating clinicians, an independent Clinical Endpoint Committee (CEC) is masked to treatment assignment when adjudicating all endpoint events (ischemic events and bleeding events) to minimize assessment bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician, Department of Cardiology

Model Details: This is a multicenter, randomized, open-label, active-controlled, non-inferiority trial with two parallel arms. Eligible participants will be randomly assigned at a 1:1 ratio to receive either low-dose aspirin (50 mg once daily) or standard-dose aspirin (100 mg once daily), both in combination with a P2Y12 inhibitor. All participants will be followed for 12 months after randomization.

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: September 29, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)