- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02494895
Ticagrelor Monotherapy After 3 Months in the Patients Treated With New Generation Sirolimus Stent for Acute Coronary Syndrome (TICO Study)
June 19, 2018 updated by: Yonsei University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
3056
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: MYEONG-KI HONG, MD, Ph.D
- Phone Number: 82-2-2228-8460
- Email: MKHONG61@yuhs.ac
Study Locations
-
-
-
Seoul, Korea, Republic of, 120-752
- Recruiting
- Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine
-
Contact:
- MYEONG-KI HONG, MD, Ph.D
- Phone Number: 82-2-2228-8460
- Email: MKHONG61@yuhs.ac
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ticagrelor monotherapy
Ticagrelor monotherapy 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 stop aspirin at 3 months after PCI.
Other Names:
|
Active Comparator: Ticagrelor with Aspirin
Ticagrelor with Aspirin DAPT(Dual Anti-platelet 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Major adverse cardiovascular clinical events (MACCE)
Time Frame: 1 year after the procedure
|
1 year after the procedure
|
|
major bleeding
Time Frame: 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.
|
1 year after the procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2015
Primary Completion (Anticipated)
May 1, 2023
Study Completion (Anticipated)
May 1, 2023
Study Registration Dates
First Submitted
July 7, 2015
First Submitted That Met QC Criteria
July 7, 2015
First Posted (Estimate)
July 10, 2015
Study Record Updates
Last Update Posted (Actual)
June 20, 2018
Last Update Submitted That Met QC Criteria
June 19, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Disease
- Syndrome
- Acute Coronary Syndrome
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Purinergic P2Y Receptor Antagonists
- Purinergic P2 Receptor Antagonists
- Purinergic Antagonists
- Purinergic Agents
- Aspirin
- Ticagrelor
Other Study ID Numbers
- 1-2014-0066
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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