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Recruiting Phase 4 NCT06451198

NCT06451198 IndObufen Versus asPirin After Coronary Drug-eluting Stent implantaTION in Elderly Patients With Acute Coronary Syndrome

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Clinical Trial Summary
NCT ID NCT06451198
Status Recruiting
Phase Phase 4
Sponsor Shanghai Zhongshan Hospital
Condition Coronary Artery Disease
Study Type INTERVENTIONAL
Enrollment 2,846 participants
Start Date 2025-05-19
Primary Completion 2028-12-31

Trial Parameters

Condition Coronary Artery Disease
Sponsor Shanghai Zhongshan Hospital
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 2,846
Sex ALL
Min Age 65 Years
Max Age N/A
Start Date 2025-05-19
Completion 2028-12-31
Interventions
IndobufenAspirinTicagrelor

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Brief 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 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

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