ClinicalTrials.gg
RecruitingNCT07846462ASPIRE-LDUpdated Oct 1, 2026

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

An interventional study of Aspirin and P2Y12 inhibitor in Coronary Artery Disease, Acute Coronary Syndromes and Chronic Coronary Syndrome, sponsored by Jilin University. Recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-01.

Sponsored by Jilin University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Mar 2026, registered Sep 2026).
  • Started Mar 2026; still recruiting 8 months later.
Updated Sep 29, 2026Newly registeredGo to Updates ↓

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Phase
Not applicable
Study type
Interventional
Enrollment
2,640
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 53 studies testing aspirin in Coronary Artery Disease — 8 open to participants now, 9 under way, 1 of them phase 3. Aspirin · Coronary Artery Disease.

Planned enrollment
12th of 53
2,640 · median 200
Started
2026
the only one that year
No phase
5 of 53
2 open now
Registered
53rd of 53
by date

Among the 53 studies testing aspirin in Coronary Artery Disease, this one is the 12th largest by planned enrollment, is the only one that started in 2026, is one of 5 with no phase, and was the 53rd registered.

Coronary Artery Disease

4,862 studies on the registry are indexed under Coronary Artery Disease; 893 are open to participants now.

Browse Coronary Artery Disease studies →

Open to participants now

8 of the 53 studies testing aspirin in Coronary Artery Disease are open now, in 6 countries. Recruiting first, the newest first:

2 more — sign in →

By country, each count listing its studies:

All 8 open studies →

About aspirin

Aspirin: first FDA approval 1950 (PERCODAN), first EMA approval 2010. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 589 Coronary Artery Disease studies recruiting now, 403 (68%) set no upper age limit and 68 (12%) stop at 75 or younger; 38 take children under 18; 48 take healthy volunteers.

This study: 18 Years to 85 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 53 studies testing aspirin in Coronary Artery Disease, or all of them as a file.
02

Study 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.

Read the detailed description

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.

03

Conditions studied

  • 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
04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 and comply with study follow-up requirements

Exclusion criteria

Exclusion Criteria:

  • Known or to aspirin, P2Y12 inhibitors, or related
  • High bleeding risk: history of intracranial hemorrhage, gastrointestinal bleeding within 6 months, active bleeding diathesis, or coagulopathy
  • Severe hepatic dysfunction ( class C) or severe renal impairment ( \< 30 mL/min/1.73 m²)
  • Ischemic or hemorrhagic stroke within 3 months before enrollment
  • Pregnant or lactating women; women of unwilling to use effective
  • \< 12 months due to other severe comorbidities such as advanced
  • 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
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,640 participants (estimated)

Study arms

  • Experimental
    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.

    Drug: Aspirin · Drug: P2Y12 inhibitor

  • Active comparator
    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.

    Drug: Aspirin · Drug: P2Y12 inhibitor

Interventions

  • 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

  • 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

06

What researchers measure

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.

    Time frame: 12 months after randomization

Secondary outcomes

  1. Incidence of Clinically Relevant Bleeding Events

    Bleeding events classified by the Bleeding Academic Research Consortium (BARC) criteria, including BARC grade 2, 3 and 5.

    Time frame: 12 months after randomization

  2. Net Adverse Clinical Events (NACE)

    Composite of all-cause death, myocardial infarction, ischemic stroke and major bleeding.

    Time frame: 12 months after randomization

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 3933848 ↗
  • 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. PubMed 16319386 ↗
  • 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. PubMed 18077812 ↗

Individual participant data

Plan to share: No — 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.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2026 (actual). Primary completion is estimated for Mar 2029, 36 months after the start.

Of 753 non-industry interventional studies with no phase under Coronary Artery Disease, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 53. This study's planned 36 months is close to that.

Counting every sponsor, half of 930 studies reached it within 30 months; a quarter within 15 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 23, 2026
First posted
Sep 29, 2026
StartActual
Mar 1, 2026
Primary completionEst.
Mar 1, 2029
CompletionEst.
Apr 1, 2029
Last update
Oct 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Sep 29, 2026
Show all 2 updates
  1. Oct 1, 2026
    Minor edits only
    + 1 other change: criteria formatting
  2. Sep 29, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07846462
Lead sponsor
Jilin University
Responsible party
Mingyou Zhang (Associate Chief Physician, Department of Cardiology, Jilin University) — Principal investigator
First posted
Sep 29, 2026
Start date
Mar 1, 2026
Primary completion
Mar 1, 2029 (estimated)
Completion
Apr 1, 2029 (estimated)
Last update
Oct 1, 2026

Study contacts

Qian Tong, MD
Contact
tongqian187@aliyun.com
'+86-13074337289'
Mingyou 'Zhang', MD
Contact
zmy@jlu.edu.cn
+86-13689842200

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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