IndObufen Versus asPirin After Coronary Drug-eluting Stent implantaTION in Elderly Patients With Acute Coronary Syndrome (OPTION2)

Fudan University

Status and phase: Not yet enrolling; Phase 4

Conditions: Coronary Artery Disease

Treatments: Drug: Aspirin; Drug: Ticagrelor; Drug: Indobufen

Study type: Interventional

Funder types: Other

Identifiers

NCT06451198

B2024-187

Details and patient eligibility

About

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 70 years old undergoing coronary drug-eluting stent (DES) implantation.

Enrollment: 2,846 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age over 70 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,846 participants in 2 patient groups

indobufen plus ticagrelor

Experimental group

Description:

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.

Treatment:

Drug: Indobufen

Drug: Ticagrelor

aspirin plus ticagrelor

Active Comparator group

Description:

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.

Treatment:

Drug: Ticagrelor

Drug: Aspirin