Indobufen versus aspirin after coronary stent in older adults with acute coronary syndrome
Official title: IndObufen Versus asPirin After Coronary Drug-eluting Stent implantaTION in Elderly Patients With Acute Coronary Syndrome
Run by Shanghai Zhongshan Hospital · NCT06451198 · Data updated 2026-11-12
This test will see if using indobufen instead of aspirin, both given with ticagrelor, is as effective and safer over one year for people over 65 who received a drug‑eluting coronary stent after an acute coronary syndrome.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 65 Years and up |
| Sex | All |
| Enrollment | 2846 (estimated) |
| Sponsor | Shanghai Zhongshan Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | May 19, 2025 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | March 12, 2026 |
| Trial ID | NCT06451198 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients older than 65 with acute coronary syndrome who received at least one drug‑eluting coronary stent and are eligible for dual antiplatelet therapy with ticagrelor.
✕Probably not a fit
Patients with recent stroke, active bleeding, need for oral anticoagulation, active cancer, severe hematologic abnormalities, or life expectancy of one year or less are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
OPTION2 is a randomized, phase 4 comparison of two dual antiplatelet regimens in patients older than 65 who undergo drug‑eluting stent implantation for acute coronary syndrome. Participants are assigned to either indobufen 100 mg twice daily plus ticagrelor 90 mg twice daily or aspirin 100 mg once daily plus ticagrelor 90 mg twice daily and are followed for one year. The trial focuses on clinical efficacy and safety outcomes over the 12‑month period. Exclusion criteria include recent stroke, active bleeding, use of oral anticoagulants, active cancer, or very limited life expectancy.
Why it matters
Potential benefit: If successful, the indobufen-based regimen could lower bleeding complications while maintaining protection against stent thrombosis and ischemic events in older patients.
How similar studies have gone: Some smaller studies and pharmacologic data suggest indobufen may reduce bleeding compared with aspirin, but large randomized head‑to‑head evidence in elderly post‑DES patients is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age over 65 years old * Diagnosed with acute coronary syndrome (unstable angina/ non-ST elevation myocardial infarction/ ST elevation myocardial infarction) * Treated with at least 1 DES implanted in the coronary lesion * Receiving dual antiplatelet therapy (aspirin plus ticagrelor) * Agree to attend the trial Exclusion Criteria: * Elective surgical procedure planned within 12 months * Life expectancy ≤1 year * Known allergy or intolerance to aspirin, ticagrelor or nonsteroidal anti-inflammatory drugs (NSAIDs) * History of cerebral hemorrhage * History of stroke in six months * Active bleeding * Known relevant hematological deviations * Known, clinically important thrombocytopenia (i.e., \<100\*10\^9/L) or anemia (i.e., \<90g/L) * Active cancer * Concomitant use of oral anticoagulants * Active participation in another clinical study * Other situations in which the investigator considers unsuitable to attend the study
Where it's running
-
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Lili Xu, Dr
- Email: lilixu1991@163.com
- Phone: 8615901823966
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.