NCT06451198

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,846 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease
• Antiplatelet Drugs

Interventions

Type	Name	Description
DRUG	Indobufen	Patients meeting the criteria are randomized before discharge from the hospital and given indobufen 100mg bid and ticagrelor 90mg bid the second day after randomization. The administration shall last 12 months.
DRUG	Aspirin	Patients meeting the criteria are randomized before discharge from the hospital and continued aspirin 100 mg qd and ticagrelor 90mg bid. The administration shall last 12 months.
DRUG	Ticagrelor	All the patients meeting the criteria and enrolled in the study are given ticagrelor 90mg bid for 12 months.

Timeline

• Start date: 2025-05-19
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2024-06-11
• Last updated: 2026-03-12

Locations

1 site across 1 country: China