NCT07542860 Aspirin 50 mg vs. 100 mg in Elderly Cardiovascular Disease Patients
| NCT ID | NCT07542860 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking University First Hospital |
| Condition | Atherosclerotic Cardiovascular Disease (ASCVD) |
| Study Type | OBSERVATIONAL |
| Enrollment | 5,448 participants |
| Start Date | 2019-04-10 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 5,448 participants in total. It began in 2019-04-10 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07542860 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Atherosclerotic Cardiovascular Disease (ASCVD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07542860 currently recruiting?
Yes, NCT07542860 is actively recruiting participants. Contact the research team at liumeilin@hotmail.com for enrollment information.
Where is the NCT07542860 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07542860 clinical trial?
NCT07542860 is sponsored by Peking University First Hospital. The trial plans to enroll 5,448 participants.