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IndObufen Versus asPirin After Coronary Drug-eluting Stent implantaTION in Elderly Patients With Acute Coronary Syndrome

RECRUITINGPhase 4Sponsored by Shanghai Zhongshan Hospital
Actively Recruiting
PhasePhase 4
SponsorShanghai Zhongshan Hospital
Started2026-02-25
Est. completion2028-12-31
Eligibility
Age65 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06451198

Summary

The OPTION2 trial (randomized controlled trial of IndObufen versus asPirin after coronary drug-eluting stent implantaTION in elderly patients with acute coronary syndrome) was designed to compare the 1-year clinical efficacy and safety of indobufen-based dual antiplatelet therapy (DAPT) (indobufen 100mg bid plus ticagrelor 90mg bid) or conventional DAPT (aspirin 100mg qd plus ticagrelor 90mg bid) in acute coronary syndrome (ACS) patients aged over 65 years old undergoing coronary drug-eluting stent (DES) implantation.

Eligibility

Age: 65 Years+Healthy volunteers accepted
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

Conditions3

Antiplatelet DrugsCoronary Artery DiseaseHeart Disease

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