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

Phase 4

• Conditions: Acute Coronary Syndrome
• Interventions: Drug: Ticagrelor monotherapy; Drug: Ticagrelor with Aspirin DAPT(dual antiplatelet treatment)

• Registration Number: NCT02494895
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-07
• Study First Submitted QC: 2015-07-07
• Study First Posted: 2015-07-10
• Study Start: 2015-08-01
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-19
• Last Update Posted: 2018-06-20
• Primary Completion: 2023-05
• Study Completion: 2023-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3056

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ticagrelor monotherapy	Ticagrelor monotherapy	Ticagrelor monotherapy at 3 months after PCI
Ticagrelor with Aspirin	Ticagrelor with Aspirin DAPT(dual antiplatelet treatment)	Ticagrelor with Aspirin DAPT(Dual Anti-platelet Treatment)

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of