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.
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.
Ticagrelor: All the patients meeting the criteria and enrolled in the study are given ticagrelor 90mg bid for 12 months.
Study 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
Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
net adverse clinical events (NACEs) — 1-year including ischemic and bleeding events, i.e., a composite of cardiovascular (CV) death, nonfatal myocardial infarction (MI), ischemic stroke, definite or probable stent thrombosis (ST), or Bleeding Academic Research Consortium (BARC) criteria type 2, 3 or 5 bleeding
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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