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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Zhongshan Hospital Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Lili Xu, Dr
lilixu1991@163.com
8615901823966
Time Frame
Start Date: 2025-05-19
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 2846
Treatments
Experimental: indobufen plus ticagrelor
Patients meeting the criteria are randomized before discharge from the hospital and given indobufen 100 mg bid and ticagrelor 90mg bid the second day after randomization. The administration shall last 12 months.
Active_comparator: aspirin plus ticagrelor
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.
Related Therapeutic Areas
Coronary Heart Disease
Acute Coronary Syndrome
Sponsors
Leads: Shanghai Zhongshan Hospital

This content was sourced from clinicaltrials.gov

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