Coronary Artery Disease, Acute Coronary Syndrome
Conditions
Brief summary
We hypothesized that ticagrelor monotherapy might be enough to prevent thromboembolic events without aspirin after PCI in patients with acute coronary syndrome(ACS). Moreover, ticagrelor monotherapy will reduce bleeding risk compared to DAPT with aspirin plus ticagrelor. We will also evaluate 1-year safety and efficacy of Orsiro stent for patient with acute coronary syndrome. After confirmation of enrollment, patients will be randomized to continue standard treatment (aspirin plus ticagrelor) for 1 year or to stop aspirin after discharge or less than 1 month after PCI (ticagrelor monotherapy). Randomization will be stratified according to 1) the presence of diabetes and 2) ST elevation myocardial infarction (MI). Baseline clinical and angiographic characteristics, laboratory findings will be assessed at the time of randomization. All patients will provide informed consent on their own initiative.
Interventions
DRUGStandard DAPT
Patient will continue standard treatment (aspirin plus ticagrelor) for 1 year. Dosage of ticagrelor would be 90 mg twice a day, and 100 mg of aspirin will be prescribed once a day.
DRUGVery-short DAPT less than 1 month after PCI
Patient will stop aspirin (ticagrelor monotherapy) after discharge or within 1 month. Dosage of ticagrelor would be 90 mg twice a day, and 100 mg of aspirin will be prescribed once a day (during hospitalization).
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients ≥19 years old 2. Patients who received new generation sirolimus-eluting (Orsiro® series) stent implantation for treating ACS, including acute MI and unstable angina 3. Provision of informed consent
Exclusion criteria
1. Age\> 80 years 2. Increased risk of bleeding, anemia, thrombocytopenia 3. A need for oral anticoagulation therapy 4. Pregnant women or women with potential childbearing 5. Life expectancy \< 1 year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Net clinical benefit | 1 year after procedure | A composite of all-cause death, MI, stent thrombosis, stroke, major bleeding |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Each components of net clinical benefit | 1 year after procedure | All-cause death, MI, stent thrombosis, stroke, major bleeding |
| Cardiovascular mortality | 1 year after procedure | Cardiovascular mortality |
| Major or minor bleeding | 1 year after procedure | Major or minor bleeding |
| Major adverse cardiac event | 1 year after procedure | A composite of cardiac death, MI, stent thrombosis, ischemia-driven target-vessel revascularization |
Countries
South Korea
Contacts
Primary ContactMyeong-Ki Hong, MD, PhD
Outcome results
None listed