Aspirin 50 mg vs. 100 mg in Elderly Cardiovascular Disease Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsorPeking University First Hospital

About this trial

Elderly patients with cardiovascular disease face a high risk of both thrombotic and bleeding events when receiving antithrombotic therapy. The optimal dose of aspirin for secondary prevention in this population remains uncertain, particularly in Chinese elderly individuals. This multicenter, prospective cohort study aims to evaluate the effectiveness and safety of a lower dose of aspirin (50 mg daily) compared with the standard dose (100 mg daily) for secondary prevention of atherosclerotic cardiovascular disease (ASCVD) in Chinese patients aged 60 years and older. The study is an extension of the existing LAPIS cohort (ChiCTR1900021980), which has enrolled 5,448 participants receiving long-term aspirin for secondary prevention. Participants will be followed for an additional 2 years (total follow-up up to approximately 6 years) through telephone, clinic visits, and electronic medical records. The primary effectiveness outcome is the first occurrence of major adverse cardiovascular events (MACE), including non-fatal myocardial infarction, unstable angina, need for revascularization, non-fatal stroke, transient ischemic attack, and cardiovascular death (excluding intracranial bleeding). The primary safety outcome is the first occurrence of bleeding events (classified by BARC criteria). A secondary aim is to develop and validate a risk prediction model (nomogram) for thrombotic and bleeding events specifically for elderly Chinese patients receiving antithrombotic therapy, using LASSO regression and Cox proportional hazards models. The study will provide real-world evidence to guide individualized antithrombotic management in the aging Chinese population.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 60 years.

Diagnosis of established atherosclerotic cardiovascular disease (ASCVD), including acute coronary syndrome, stable coronary artery disease, post-revascularization (percutaneous coronary intervention or coronary artery bypass grafting), ischemic cardiomyopathy, ischemic stroke, transient ischemic attack, or peripheral artery disease.

Long-term use of aspirin (≥1 year) for secondary prevention of ASCVD.

Available laboratory tests (within the past 3 months): complete blood count, urinalysis, routine stool examination and occult blood test, liver and kidney function, electrolytes, glucose, lipids, uric acid, coagulation function, etc.

Disqualifiers

Hypersensitivity to aspirin or other salicylates, or any other component of the drug product; history of asthma induced by salicylates or nonsteroidal anti-inflammatory drugs (NSAIDs), or any other condition that, in the clinical judgment, makes the patient unsuitable for study participation.

Life expectancy ≤ 2 years due to non-cardiovascular causes.

Poor compliance (unable to adhere to prescribed medication or follow scheduled follow-up visits as judged by the investigator).

Trial population

Chinese patients aged ≥60 years with established ASCVD receiving long-term aspirin (50 mg or 100 mg daily) for secondary prevention. This population is a subset (N=5,448) of the LAPIS multicenter prospective cohort, enrolled from 71 centers across China between April 2019 and the end of recruitment. No new enrollment is ongoing; participants are followed prospectively.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

5,448 Participants
are grouped into 2 trial groups
Group A: Aspirin 50 mg daily
Group B: Aspirin 100 mg daily

Trial outcomes

Primary outcomes

1

Major Adverse Cardiovascular Events

First occurrence of the composite of non-fatal myocardial infarction, unstable angina, need for surgical or percutaneous revascularization, non-fatal stroke, transient ischemic attack, and cardiovascular death (excluding intracranial bleeding)

Time frame
Up to approximately 6 years (from enrollment through study completion, with follow-up visits every 6 months)
2

Bleeding Events

First occurrence of bleeding events classified by BARC (Bleeding Academic Research Consortium) criteria, including fatal bleeding (type 5), major bleeding (type 3-4), and minor bleeding (type 1-2).

Time frame
Up to approximately 6 years (from enrollment through study completion, with follow-up visits every 6 months)

Secondary outcomes

Other outcomes

Sponsors and contacts

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Peking University First Hospital

Lead sponsor

Peking University Third Hospital

Collaborator