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

Yonsei University

Status and phase: Unknown; Phase 4

Conditions: Acute Coronary Syndrome

Treatments: Drug: Ticagrelor monotherapy; Drug: Ticagrelor with Aspirin DAPT(dual antiplatelet treatment)

Study type: Interventional

Funder types: Other

Identifiers

NCT02494895

1-2014-0066

Details and patient eligibility

About

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.

Enrollment: 3,056 estimated patients

Sex: All

Ages: 19 to 79 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,056 participants in 2 patient groups

Ticagrelor monotherapy

Experimental group

Description:

Ticagrelor monotherapy at 3 months after PCI

Treatment:

Drug: Ticagrelor monotherapy

Ticagrelor with Aspirin

Active Comparator group

Description:

Ticagrelor with Aspirin DAPT(Dual Anti-platelet Treatment)

Treatment:

Drug: Ticagrelor with Aspirin DAPT(dual antiplatelet treatment)