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Acute Coronary SyndromePhase 4NCT02494895

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

A Phase 4 study testing Ticagrelor monotherapy and Ticagrelor with Aspirin DAPT(dual antiplatelet treatment) in people with Acute Coronary Syndrome, run by Yonsei University at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 79 years
Conditions the study is for
Acute Coronary Syndrome
What is being tested?
Ticagrelor monotherapy and Ticagrelor with Aspirin DAPT(dual antiplatelet treatment)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,056 participants
Where
1 siteSouth Korea
Study dates
1 Aug 2015to May 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 9Show fewer
  • Patients who had history of intracranial hemorrhage
  • Moderate to severe hepatic dysfunction
  • Increased risk of bradycardia-related symptom (Guidance and reference)

Trial locations and contacts

1 site in 1 country.

Myeong-Ki Hong, MD, Ph.D contact

82-2-2228-8460

mkhong61@yuhs.ac

South Korea1 site, 1 recruiting

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

    Seoul, 120-752

    MYEONG-KI HONG, MD, Ph.D, 82-2-2228-8460, MKHONG61@yuhs.ac

    Recruiting

Other trials in South Korea

About this study

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.

Being tested
Ticagrelor monotherapy, Ticagrelor with Aspirin DAPT(dual antiplatelet treatment)
Medical subject headings
Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ticagrelor monotherapyDrug

    Also called Brilinta®

    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 DAPT(dual antiplatelet treatment)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.

Study groups in NCT02494895
Study groupRoleWhat they receive
Ticagrelor monotherapyExperimentalTicagrelor monotherapy at 3 months after PCI
Receives: Drug: Ticagrelor monotherapy
Ticagrelor with AspirinActive comparatorTicagrelor with Aspirin DAPT(Dual Anti-platelet Treatment)
Receives: Drug: Ticagrelor with Aspirin DAPT(dual antiplatelet treatment)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major adverse cardiovascular clinical events (MACCE)

    Measured: 1 year after the procedure

  2. 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.

    Measured: 1 year after the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2015 (estimated)
  2. Study start1 Aug 2015
  3. Primary completionMay 2023 (estimated)
  4. Study completionMay 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,056 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02494895
Sponsor's protocol ID
1-2014-0066
Status last verified
Jun 2018
First submitted
7 Jul 2015
Last updated
20 Jun 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Lee JH, Lee J, Kim SY, Jeon HS, Lee JW, Ahn SG, Lee YJ, Lee SJ, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Hong MK, Jang Y, Hong SJ, Youn YJ. Optimal timing of aspirin discontinuation with ticagrelor monotherapy in acute coronary syndrome: a post hoc comparative analysis from the TICO and T-PASS trials. EuroIntervention. 2026 Feb 16;22(4):232-242. doi: 10.4244/EIJ-D-25-00832.

    PubMed 41697655

  • 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.

    PubMed 41044734

  • 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.

    PubMed 37614943

  • 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.

    PubMed 37063970

  • 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.

    PubMed 35129317

  • 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.

    PubMed 34281363

  • 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.

    PubMed 34083627

  • 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.

    PubMed 33739127

  • 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.

    PubMed 33602439

  • 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.

    PubMed 33519487

  • 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.

    PubMed 32543684

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ticagrelor monotherapy and Ticagrelor with Aspirin DAPT(dual antiplatelet treatment) in people with Acute Coronary Syndrome, run by Yonsei University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Myeong-Ki Hong, MD, Ph.D (82-2-2228-8460, mkhong61@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major adverse cardiovascular clinical events (MACCE) (time frame: 1 year after the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02494895, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2018.

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