IndObufen Versus asPirin After Coronary Drug-eluting Stent implantaTION in Elderly Patients With Acute Coronary Syndrome
Overview
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Shanghai Zhongshan Hospital
- Enrollment
- 2,846
- Locations
- 1
- Primary Endpoint
- net adverse clinical events (NACEs)
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
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.
Intervention: Indobufen (Drug)
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.
Intervention: Ticagrelor (Drug)
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.
Intervention: Aspirin (Drug)
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.
Intervention: Ticagrelor (Drug)
Outcomes
Primary Outcomes
net adverse clinical events (NACEs)
Time Frame: 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 Outcomes
- BARC criteria type 2, 3 or 5 bleeding events(1-year)
- a composite endpoint of CV death, nonfatal MI, ischemic stroke, definite or probable ST, or BARC criteria type 3 or 5 bleeding(1-year)
- a composite of CV death, nonfatal MI, ischemic stroke, definite or probable ST(1-year)
- all-cause mortality(1-year)
Investigators
Junbo Ge
Professor
Shanghai Zhongshan Hospital