Ticagrelor Monotherapy After 3 Months in the Patients Treated With New Generation Sirolimus Stent for Acute Coronary Syndrome (TICO Study)
1 other identifier
interventional
3,056
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2015
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2015
CompletedFirst Posted
Study publicly available on registry
July 10, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2023
CompletedJune 20, 2018
June 1, 2018
7.8 years
July 7, 2015
June 19, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
Ticagrelor monotherapy
EXPERIMENTALTicagrelor monotherapy at 3 months after PCI
Ticagrelor with Aspirin
ACTIVE COMPARATORTicagrelor with Aspirin DAPT(Dual Anti-platelet Treatment)
Interventions
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 (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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine
Seoul, 120-752, South Korea
Related Publications (10)
Jin IT, Kim Y, Heo SJ, Lee YJ, Lee SJ, Hong SJ, Ahn CM, Kim JS, Cho DK, Ko YG, Choi D, Hong MK, Kim BK. Comparison of Short-term and Standard Duration Dual Antiplatelet Therapy in Elderly Patients: A Pooled Analysis of Five Korean Randomized Clinical Trials. Korean Circ J. 2025 Dec;55(12):1125-1137. doi: 10.4070/kcj.2025.0093. Epub 2025 Jul 14.
PMID: 41044734DERIVEDCho JY, Joo D, Yun KH, Kim BK, Hong MK, Jang Y, Oh SK. Clinical implication of ticagrelor monotherapy in patients with small vessel coronary artery disease: results from the TICO randomized trial. Front Cardiovasc Med. 2023 Aug 8;10:1237826. doi: 10.3389/fcvm.2023.1237826. eCollection 2023.
PMID: 37614943DERIVEDKim BG, Hong SJ, Kim BK, Lee YJ, Lee SJ, Ahn CM, Shin DH, Kim JS, Ko YG, Choi D, Hong MK, Jang Y. Body mass index affecting ticagrelor monotherapy vs. ticagrelor with aspirin in patients with acute coronary syndrome: A pre-specified sub-analysis of the TICO randomized trial. Front Cardiovasc Med. 2023 Mar 30;10:1128834. doi: 10.3389/fcvm.2023.1128834. eCollection 2023.
PMID: 37063970DERIVEDLee YJ, Suh Y, Kim JS, Cho YH, Yun KH, Kim YH, Cho JY, Her AY, Cho S, Jeon DW, Yoo SY, Cho DK, Hong BK, Kwon H, Hong SJ, Ahn CM, Shin DH, Nam CM, Kim BK, Ko YG, Choi D, Hong MK, Jang Y; TICO investigators. Ticagrelor Monotherapy After 3-Month Dual Antiplatelet Therapy in Acute Coronary Syndrome by High Bleeding Risk: The Subanalysis From the TICO Trial. Korean Circ J. 2022 Apr;52(4):324-337. doi: 10.4070/kcj.2021.0321. Epub 2021 Dec 28.
PMID: 35129317DERIVEDLee SJ, Lee YJ, Kim BK, Hong SJ, Ahn CM, Kim JS, Ko YG, Choi D, Hong MK, Jang Y. Ticagrelor Monotherapy Versus Ticagrelor With Aspirin in Acute Coronary Syndrome Patients With a High Risk of Ischemic Events. Circ Cardiovasc Interv. 2021 Aug;14(8):e010812. doi: 10.1161/CIRCINTERVENTIONS.121.010812. Epub 2021 Jul 20.
PMID: 34281363DERIVEDKim YH, Her AY, Kim BK, Hong SJ, Ahn CM, Kim JS, Ko YG, Choi D, Hong MK, Jang Y. Impact of preprocedural coronary flow grade on duration of dual antiplatelet therapy in acute myocardial infarction. Sci Rep. 2021 Jun 3;11(1):11735. doi: 10.1038/s41598-021-91130-5.
PMID: 34083627DERIVEDCho JY, Lee SY, Yun KH, Kim BK, Hong SJ, Ko JS, Rhee SJ, Oh SK, Shin DH, Ahn CM, Kim JS, Ko YG, Choi D, Hong MK, Jang Y. Factors Related to Major Bleeding After Ticagrelor Therapy: Results from the TICO Trial. J Am Heart Assoc. 2021 Apr 6;10(7):e019630. doi: 10.1161/JAHA.120.019630. Epub 2021 Mar 19.
PMID: 33739127DERIVEDLee SJ, Cho JY, Kim BK, Yun KH, Suh Y, Cho YH, Kim YH, Her AY, Cho S, Jeon DW, Yoo SY, Cho DK, Hong BK, Kwon HM, Hong SJ, Ahn CM, Shin DH, Nam CM, Kim JS, Ko YG, Choi D, Hong MK, Jang Y; TICO Investigators. Ticagrelor Monotherapy Versus Ticagrelor With Aspirin in Patients With ST-Segment Elevation Myocardial Infarction. JACC Cardiovasc Interv. 2021 Feb 22;14(4):431-440. doi: 10.1016/j.jcin.2020.11.036.
PMID: 33602439DERIVEDYun KH, Cho JY, Lee SY, Rhee SJ, Kim BK, Hong MK, Jang Y, Oh SK; TICO Investigators. Ischemic and Bleeding Events of Ticagrelor Monotherapy in Korean Patients With and Without Diabetes Mellitus: Insights From the TICO Trial. Front Pharmacol. 2021 Jan 14;11:620906. doi: 10.3389/fphar.2020.620906. eCollection 2020.
PMID: 33519487DERIVEDKim BK, Hong SJ, Cho YH, Yun KH, Kim YH, Suh Y, Cho JY, Her AY, Cho S, Jeon DW, Yoo SY, Cho DK, Hong BK, Kwon H, Ahn CM, Shin DH, Nam CM, Kim JS, Ko YG, Choi D, Hong MK, Jang Y; TICO Investigators. Effect of Ticagrelor Monotherapy vs Ticagrelor With Aspirin on Major Bleeding and Cardiovascular Events in Patients With Acute Coronary Syndrome: The TICO Randomized Clinical Trial. JAMA. 2020 Jun 16;323(23):2407-2416. doi: 10.1001/jama.2020.7580.
PMID: 32543684DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2015
First Posted
July 10, 2015
Study Start
August 1, 2015
Primary Completion
May 1, 2023
Study Completion
May 1, 2023
Last Updated
June 20, 2018
Record last verified: 2018-06