Ticagrelor Monotherapy After 3 Months in the Patients Treated With New Generation Sirolimus Stent for Acute Coronary Syndrome (TICO Study)

Study Overview
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Brief Summary
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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.

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Drug: Ticagrelor monotherapy
* Drug: Ticagrelor with Aspirin DAPT(dual antiplatelet treatment)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ticagrelor monotherapy<br>Ticagrelor monotherapy at 3 months after PCI | Drug: Ticagrelor monotherapy<br>* 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.<br>* Other names: Brilinta®;|
| Active Comparator: Ticagrelor with Aspirin<br>Ticagrelor with Aspirin DAPT(Dual Anti-platelet Treatment) | Drug: Ticagrelor with Aspirin DAPT(dual antiplatelet treatment)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiovascular clinical events (MACCE) |  | 1 year after the procedure | 
| major bleeding | 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. | 1 year after the procedure |