Comparing 50 mg and 100 mg daily aspirin for older adults with cardiovascular disease

Risk Assessment and Application of Antithrombotic Therapy in Elderly Patients With Cardiovascular Disease: A Multicenter, Prospective Cohort Study

This tests whether taking 50 mg of aspirin daily works as well as 100 mg but causes fewer bleeding problems in Chinese people aged 60 and older with prior heart or blood vessel disease.

Quick facts

• Study type: Observational
• Enrollment: 5448 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: Peking University First Hospital (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT07542860 on ClinicalTrials.gov

What this trial studies

This is a multicenter, prospective cohort extension of the LAPIS cohort that compares long-term outcomes for Chinese patients aged 60+ taking 50 mg versus 100 mg of aspirin daily for secondary prevention of atherosclerotic cardiovascular disease. The study follows participants for an additional two years (up to about six years total) and collects outcomes by telephone, clinic visits, and review of electronic medical records. The primary effectiveness outcome is the first occurrence of major adverse cardiovascular events (MACE) and safety outcomes focus on bleeding events. The cohort builds on prior enrollment of thousands of participants receiving long-term aspirin for secondary prevention.

Who should consider this trial

Good fit: Chinese patients aged 60 or older with established atherosclerotic cardiovascular disease who have been taking aspirin long-term for secondary prevention are the ideal candidates.

Not a fit: Patients with aspirin allergy or aspirin-induced asthma, those who require other antithrombotic regimens, or people outside the study population (for example much younger or non-Chinese patients) may not benefit from these findings.

Why it matters

Potential benefit: If successful, a lower aspirin dose could maintain cardiovascular protection while reducing bleeding and gastrointestinal side effects in older Chinese patients.

How similar studies have performed: Small prior studies and the investigators' single-center data suggested similar antiplatelet effects and fewer GI adverse events with lower aspirin doses, but large multicenter evidence in elderly Chinese patients is still limited.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 60 years.
2. 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.
3. Long-term use of aspirin (≥1 year) for secondary prevention of ASCVD.
4. 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.
5. Willing to provide written informed consent.

Exclusion Criteria:

1. 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.
2. Life expectancy ≤ 2 years due to non-cardiovascular causes.
3. Poor compliance (unable to adhere to prescribed medication or follow scheduled follow-up visits as judged by the investigator).

Where this trial is running

Beijing

• Peking University First Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Meilin Liu, MD

Conditions Atherosclerotic Cardiovascular Disease; Secondary Prevention; Cardiovascular Diseases; Aspirin; Aged; Risk Assessment