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

NCT07542860 | Recruiting

• 2 other identifiers: 2025R0244TY2025011
• Study Type: observational
• Target: 5,448
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atherosclerotic Cardiovascular Disease (ASCVD); Secondary Prevention; Cardiovascular Diseases

Keywords

Aspirin; Secondary Prevention; Cardiovascular Diseases; Aged; Risk Assessment

Outcome Measures

Primary Outcomes (2)

• 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)

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

• 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).

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

Study Arms (2)

Aspirin 50 mg daily

Participants receiving long-term aspirin 50 mg daily for secondary prevention of ASCVD.

Aspirin 100 mg daily

Participants receiving long-term aspirin 100 mg daily for secondary prevention of ASCVD.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.
• Willing to provide written informed consent.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Peking University First Hospital: lead
• Peking University Third Hospital: collaborator

Study Sites (1)

Peking University First Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Atherosclerosis; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Meilin Liu, MD

CONTACT

+86-010-83572022; liumeilin@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 21, 2026
• Study Start: April 10, 2019
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)