NCT07846462Recruiting
Aspirin 50mg vs 100mg Combined With P2Y12 Inhibitor After PCI
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
Source: ClinicalTrials.gov · Last updated 1 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 2640 (estimated)
- First submitted
- 23 Sept 2026
- Start date
- 1 Mar 2026
- Primary completion date
- 1 Mar 2029
- Lead sponsor
- Jilin University
- Diseases
- Coronary artery disease
- NCT number
- NCT07846462
What you commit to
- Study type: Interventional
- Planned participants: 2640
- From 1 Mar 2026 to the primary completion date, 1 Mar 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Ischemic or hemorrhagic stroke within 3 months before enrollment
- Participation in another interventional clinical trial within 30 days before screening
Other illness
- 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
- Life expectancy \< 12 months due to other severe comorbidities such as advanced malignancy
- Any other condition judged by the investigator to make the patient unsuitable for the study
Lab values
- Severe hepatic dysfunction (Child-Pugh class C) or severe renal impairment (eGFR \< 30 mL/min/1.73 m²)
Other
- Pregnant or lactating women; women of childbearing potential unwilling to use effective contraception
Who the study is looking for
- 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
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.