IndObufen Versus asPirin After Coronary Drug-eluting Stent implantaTION in Elderly Patient
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 ticagr
| Condition(s) | Coronary Artery Disease, Antiplatelet Drugs |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 or |
| Ages | 65 Years |
| Sex | All |
| Lead sponsor | Shanghai Zhongshan Hospital |
| Locations | Shanghai, Shanghai Municipality, China |
| Start date | 2025-05-19 |
| NCT ID | NCT06451198 |
| Official listing | https://clinicaltrials.gov/study/NCT06451198 |