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

Acute Coronary Syndrome Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02494895
• Other study ID #: 1-2014-0066
• Status: Recruiting
• Phase: Phase 4
• Start date: August 1, 2015
• Est. completion date: May 2023

Study information

• Verified date: June 2018
• Source: Yonsei University
• Contact: Myeong-Ki Hong, MD, Ph.D
• Phone: 82-2-2228-8460
• Email: mkhong61[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3056
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 79 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• Ticagrelor monotherapy
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.
• Ticagrelor 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.

Locations

Country	Name	City	State
Korea, Republic of	Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiovascular clinical events (MACCE)		1 year after the procedure
Primary	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