IndObufen Versus asPirin After Coronary Drug-eluting Stent implantaTION in Elderly Patients With Acute Coronary Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Indobufen, Aspirin, Ticagrelor.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease, Antiplatelet Drugs. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Drug 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. - Drug 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. - Drug Ticagrelor
All the patients meeting the criteria and enrolled in the study are given ticagrelor 90mg bid for 12 months.
Primary outcome measures
- net adverse clinical events (NACEs) [Time frame: 1-year]
Secondary outcome measures (4)
- a composite of CV death, nonfatal MI, ischemic stroke, definite or probable ST [Time frame: 1-year]
- BARC criteria type 2, 3 or 5 bleeding events [Time frame: 1-year]
- a composite endpoint of CV death, nonfatal MI, ischemic stroke, definite or probable ST, or BARC criteria type 3 or 5 bleeding [Time frame: 1-year]
- all-cause mortality [Time frame: 1-year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Zhongshan Hospital Fudan University — Shanghai
Identifiers
NCT: NCT06451198 · B2024-187