Back to resultsTicagrelor Monotherapy After 3 Months in the Patients Treated With New Generation Sirolimus Stent for Acute Coronary Syndrome (TICO Study)
Primary Purpose
Acute Coronary Syndrome
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ticagrelor monotherapy
Ticagrelor with Aspirin DAPT(dual antiplatelet treatment)
Sponsored by
About this trial
This is an interventional treatment trial for Acute Coronary Syndrome
Eligibility Criteria
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)
Sites / Locations
- Division of Cardiology, Department of Internal Medicine, Yonsei University College of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ticagrelor monotherapy
Ticagrelor with Aspirin
Arm Description
Ticagrelor monotherapy at 3 months after PCI
Ticagrelor with Aspirin DAPT(Dual Anti-platelet Treatment)
Outcomes
Primary Outcome Measures
Major adverse cardiovascular clinical events (MACCE)
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02494895
Brief Title
Ticagrelor Monotherapy After 3 Months in the Patients Treated With New Generation Sirolimus Stent for Acute Coronary Syndrome (TICO Study)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2015 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3056 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ticagrelor monotherapy
Arm Type
Experimental
Arm Description
Ticagrelor monotherapy at 3 months after PCI
Arm Title
Ticagrelor with Aspirin
Arm Type
Active Comparator
Arm Description
Ticagrelor with Aspirin DAPT(Dual Anti-platelet Treatment)
Intervention Type
Drug
Intervention Name(s)
Ticagrelor monotherapy
Other Intervention Name(s)
Brilinta®
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ticagrelor with Aspirin DAPT(dual antiplatelet treatment)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Major adverse cardiovascular clinical events (MACCE)
Time Frame
1 year after the procedure
Title
major bleeding
Description
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.
Time Frame
1 year after the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Myeong-Ki Hong, MD, Ph.D
Phone
82-2-2228-8460
Email
mkhong61@yuhs.ac
Facility Information:
Facility Name
Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MYEONG-KI HONG, MD, Ph.D
Phone
82-2-2228-8460
Email
MKHONG61@yuhs.ac
12. IPD Sharing Statement
Citations:
PubMed Identifier
35129317
Citation
Lee 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.
Results Reference
derived
PubMed Identifier
34281363
Citation
Lee 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.
Results Reference
derived
PubMed Identifier
34083627
Citation
Kim 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.
Results Reference
derived
PubMed Identifier
33739127
Citation
Cho 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.
Results Reference
derived
PubMed Identifier
33602439
Citation
Lee 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.
Results Reference
derived
PubMed Identifier
33519487
Citation
Yun 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.
Results Reference
derived
PubMed Identifier
32543684
Citation
Kim 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.
Results Reference
derived
Learn more about this trial
Ticagrelor Monotherapy After 3 Months in the Patients Treated With New Generation Sirolimus Stent for Acute Coronary Syndrome (TICO Study)
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