Aspirin 50 mg vs 100 mg with a P2Y12 inhibitor after PCI
Official title: 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
Run by Jilin University · NCT07846462 · Data updated 2026-11-12
This trial tests whether a 50 mg daily aspirin dose, when used with a P2Y12 inhibitor after PCI, works as well as 100 mg with similar safety for people staying on DAPT for 12 months.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 2640 (estimated) |
| Sponsor | Jilin University Academic / other |
| Locations | 1 site (Changchun, Jilin) |
| Status | Recruiting |
| Started | March 1, 2026 |
| Main results expected | March 1, 2029 |
| Study ends | April 1, 2029 |
| Registry record updated | October 1, 2026 |
| Trial ID | NCT07846462 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–85 with ACS or CCS who have successfully undergone PCI and plan at least 12 months of DAPT.
✕Probably not a fit
Patients at high bleeding risk or those who do not respond adequately to low-dose aspirin may not benefit and could be exposed to risk without advantage.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter, open-label, randomized non-inferiority study in China compares low-dose (50 mg) versus standard-dose (100 mg) enteric-coated aspirin, each plus a P2Y12 inhibitor, in adults who have recently had PCI and will continue DAPT for at least 12 months. Participants are randomized 1:1 and followed for 12 months, with MACCE and safety outcomes adjudicated by an independent committee. The choice of P2Y12 inhibitor (ticagrelor or clopidogrel) is per physician discretion. An independent data monitoring committee oversees safety, and events are defined by standardized international criteria.
Why it matters
Potential benefit: If 50 mg aspirin is non-inferior, patients could have similar protection with potentially lower bleeding risk and exposure to a smaller aspirin dose.
How similar studies have gone: Previous research suggests low-dose aspirin may provide comparable antiplatelet effects with similar safety in some settings, but results vary by population and regimen.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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First Hospital of Jilin University
Changchun, Jilin, China Recruiting
Study contacts
- Study coordinator: Qian Tong, MD
- Email: tongqian187@aliyun.com
- Phone: '+86-13074337289'
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.