Ticagrelor Monotherapy after 3 months in the Patients treated with New Generation Sirolimus-Eluting Stents for Acute Coronary Syndrome

Not Applicable

Completed

Conditions: Diseases of the circulatory system

Registration Number: KCT0002935

Lead Sponsor: Yonsei University Health System, Severance Hospital

Brief Summary: Among patients who treated with DES for acute coronary syndrome, the incidence of net adverse clinical event was significantly lower in those with the ticagrelor monotherapy after 3-month DAPT than those with the currently recommended ticagrelor-based 12-month DAPT, mainly driven by lower major bleeding.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 3056

Inclusion Criteria

1. Patients = 19 years old 2. Patients who received new
generation sirolimus-eluting (Osiro®) stent implantation for treating ACS,
including acute MI and unstable angina 3. Patients without significant clinical
events such as MI, stent thrombosis or revascularization until 3 months after
PCI 4. 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 6. Patients
receiving a potent CYP3A4 inhibitor (eg, ketoconazole, clarithromycin,
napjodone, ritonavir, atazanavir) 7. Patients with a history of intracranial
bleeding 8. Patients with moderate to severe hepatic impairment 9. Patients at
risk of bradykinesia (based on licensing and clinical
literature)

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MACCE composed of cardiovascular mortality, myocardial infarction, <br>stent thrombosis, stroke or target vessel revascularization and major bleeding <br>at 1 year after PCI procedure

Secondary Outcome Measures