Acute Coronary Syndrome
Conditions
Brief summary
To compare the clinical outcomes of dual antiplatelet therapy with aspirin and ticagrelor vs. ticagrelor monotherapy at 3 months after PCI in patients with acute coronary syndrome.
Interventions
Ticagrelor (Brilinta®) is indicated for the prevention of thrombotic events (for example stroke or heart attack) in people with acute coronary syndrome or myocardial infarction with ST elevation. Patients will be randomized to stop aspirin at 3 months after PCI.
DRUGTicagrelor with Aspirin DAPT(dual antiplatelet treatment)
Ticagrelor (Brilinta®) is indicated for the prevention of thrombotic events (for example stroke or heart attack) in people with acute coronary syndrome or myocardial infarction with ST elevation. Patients will be randomized to continue DAPT (aspirin+ticagrelor) up to 1 year.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Patients ≥ 19 years old * Patients who received new generation sirolimus-eluting (Osiro®) stent implantation for treating ACS * Patients without significant clinical events such as MI, stent thrombosis or revascularization until 3 months after PCI * Provision of informed consent
Exclusion criteria
* Age \> 80 years * Increased risk of bleeding, anemia, thrombocytopenia * A need for oral anticoagulation therapy * Pregnant women or women with potential childbearing * Life expectancy \< 1 year * Patients who treated with strong CYP3A4 inhibitors (e.g. ketoconazole, clarithromycin, nefazodone, ritonavir, or atazanavir) * Patients who had history of intracranial hemorrhage * Moderate to severe hepatic dysfunction * Increased risk of bradycardia-related symptom (Guidance and reference)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiovascular clinical events (MACCE) | 1 year after the procedure | — |
| major bleeding | 1 year after the procedure | Major bleeding means 1) any intracranial bleeding (excluding microhemorrhages \<10 mm evident only on gradient-echo MRI), 2) clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥5 g/dL or a ≥15% absolute decrease in haematocrit, and 3) fatal bleeding (bleeding that directly results in death within 7 days) in accordance with TIMI Bleeding Criteria. |
Countries
South Korea
Contacts
Primary ContactMyeong-Ki Hong, MD, Ph.D
Outcome results
None listed