Antiplatelet Drugs, Coronary Artery Disease
Conditions
Brief 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.
Interventions
DRUGIndobufen
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.
DRUGAspirin
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.
DRUGTicagrelor
All the patients meeting the criteria and enrolled in the study are given ticagrelor 90mg bid for 12 months.
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| a composite of CV death, nonfatal MI, ischemic stroke, definite or probable ST | 1-year | ischemic events |
| BARC criteria type 2, 3 or 5 bleeding events | 1-year | bleeding events |
| a composite endpoint of CV death, nonfatal MI, ischemic stroke, definite or probable ST, or BARC criteria type 3 or 5 bleeding | 1-year | key composite endpoint |
| all-cause mortality | 1-year | death from any cause |
Countries
China
Contacts
CONTACTLili Xu, Dr
Outcome results
None listed