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

NCT ID: NCT02494895

Last Updated: 2018-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

3056 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-01

Study Completion Date

2023-05-31

Brief Summary

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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

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Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ticagrelor monotherapy

Ticagrelor monotherapy at 3 months after PCI

Group Type EXPERIMENTAL

Ticagrelor monotherapy

Intervention Type DRUG

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 with Aspirin

Ticagrelor with Aspirin DAPT(Dual Anti-platelet Treatment)

Group Type ACTIVE_COMPARATOR

Ticagrelor with Aspirin DAPT(dual antiplatelet treatment)

Intervention Type DRUG

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.

Interventions

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Ticagrelor monotherapy

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

Ticagrelor with Aspirin DAPT(dual antiplatelet 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.

Intervention Type DRUG

Other Intervention Names

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Brilinta®

Eligibility Criteria

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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)
Minimum Eligible Age

19 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Myeong-Ki Hong, MD, Ph.D

Role: CONTACT

82-2-2228-8460

Facility Contacts

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MYEONG-KI HONG, MD, Ph.D

Role: primary

82-2-2228-8460

References

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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 Jul 14. doi: 10.4070/kcj.2025.0093. Online ahead of print.

Reference Type DERIVED
PMID: 41044734 (View on PubMed)

Cho 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.

Reference Type DERIVED
PMID: 37614943 (View on PubMed)

Kim 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.

Reference Type DERIVED
PMID: 37063970 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35129317 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34281363 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34083627 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33739127 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33602439 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33519487 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32543684 (View on PubMed)

Other Identifiers

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1-2014-0066

Identifier Type: -

Identifier Source: org_study_id

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