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Coronary StenosesPhase 4TAILORED-CHIPNCT03465644

TAILored Versus COnventional AntithRombotic StratEgy IntenDed for Complex HIgh-Risk PCI

A Phase 4 study testing Tailored antithrombotic strategy and Conventional antithrombotic strategy in people with Coronary Stenoses, run by Duk-Woo Park, MD at 22 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study evaluates the efficacy and safety of tailored antithrombotic therapy with early (<6-month post-PCI) intensified (low-dose ticagrelor [120 mg loading, then 60 mg bid maintenance] and aspirin) and late (>6-month post-PCI) deescalated (clopidogrel alone) strategy in patients undergoing high-risk complex PCI as… Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Coronary Stenoses
What is being tested?
Tailored antithrombotic strategy and Conventional antithrombotic strategy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,018 participants
Where
22 sitesSouth Korea
Study dates
12 Feb 2019to 13 Feb 2025
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 19 and more
  • Subjects who scheduled for percutaneous coronary intervention(PCI) with contemporary drug-eluting stent
  • Patients must have at least one of any features of complex high-risk anatomic, procedural, or clinical-related factors;
  • Clinical factors: diabetes, chronic kidney disease (i.e. creatinine clearance <60 mL/min), or low left ventricular ejection fraction (<40%) or
  • Lesion- or procedure-related factors: left main PCI, chronic total occlusion, bifurcation lesion requiring two-stent technique, severe calcification, diffuse long lesion (lesion length ≥ at least 30 mm), multi-vessel PCI (≥ 2 vessels requiring stent implantation), ≥3 requiring stent implantation, ≥ 3 lesions will be treated, or predicted total stent length for revascularization > 60 mm
  • The patient or guardian agreed to the study protocol and the schedule of clinical follow-up and provided informed, written consent, as approved by the appropriate institutional review board/ethical committee of the respective clinical site.

Who cannot join

  • Enzyme-positive Acute myocardial infarction (non-ST-elevation myocardial infarction (NSTEMI) or ST Elevation Myocardial Infarction (STEMI))
  • Contraindication to aspirin or P2Y12 inhibitors (ticagrelor or clopidogrel)
  • Use of Gp IIb/IIIa inhibitors at randomization
  • Cardiogenic shock
  • Treatment with only bare-metal stent (BMS) or balloon angioplasty during the index procedure.
  • Requirements for chronic oral anticoagulation (warfarin or Non-vitamin K antagonist oral anticoagulant (NOACs))
Show all 18Show fewer
  • Active bleeding or extreme-risk for major bleeding (e.g. active peptic ulcer disease, gastrointestinal pathology with a high risk for bleeding, malignancies with a high risk for bleeding)
  • History of intracranial hemorrhage or intracranial aneurysm
  • Planned surgery within 180 days
  • Severe liver disease (ascites and/or coagulopathy) or Dialysis-dependent renal failure at screening
  • Platelet count <80,000 cells/mm3 or hemoglobin level <10 g/dL
  • At risk of bradycardia (subjects with sinus node dysfunction or atrioventricular block more than 2nd degree but without a permanent pacemaker)
  • Use of strong cytochrome P-450 3A inhibitor or inducers within 2 week of the date of enrollment
  • : ketoconazole, clarithromycin, nefazodone, ritonavir, atazanavir, rifampin/rifampicin, rifabutin, dexamethasone, phenytoin, carbamazepine, phenobarbital
  • Pregnant and/or lactating women.
  • Concurrent medical condition with a life expectancy of less than 1 years
  • Active participation in another investigational study of a drug or device that has not completed the primary endpoint or follow-up period
  • Inability to provide written informed consent or participate in long-term follow-up

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

South Korea22 sites

  • Hallym University Sacred Heart Hospital

    Anyang

  • Soon Chun Hyang University Hospital Bucheon

    Bucheon-si

  • Gyeongsang National University Changwon Hospital

    Changwon

  • Chungbuk National University Hospital

    Cheonju

  • Gangwon National Univ. Hospital

    Chuncheon

  • Daegu Catholic University Medical Center

    Daegu

  • Keimyung University Dongsan Medical Center

    Daegu

  • Gangneung Asan Hospital

    Gangneung

  • Chonnam National University Hospital

    Gwangju

  • Dong-A Medical Center

    Pusan

  • Inje University Pusan Paik Hospital

    Pusan

  • Pusan National University Hospital

    Pusan

  • Bundang CHA Hospital

    Seongnam

  • Seoul university Bundang hospital

    Seongnam-si

  • Asan Medical Center

    Seoul

  • Chung-Ang University Hospital

    Seoul

  • Korea University Guro Hospital

    Seoul

  • The Catholic Univ. of Korea Eunpyeong St. Mary's hospital

    Seoul

  • The Catholic University of Korea, Yeouido St. Mary's Hospital

    Seoul

  • St.Carollo Hospital

    Suncheon

  • The Catholic University of Korea, ST. Mary's Hospital

    Suwon

  • Ulsan University Hospital

    Ulsan

Other trials in South Korea

About this study

Official title: Comparison of Tailored Antiplatelet Therapy With Early Escalation and Late De-Escalation Strategy Versus Standard Dual Antiplatelet Therapy in Patients Undergoing Complex High-Risk Percutaneous Coronary Intervention

This study evaluates the efficacy and safety of tailored antithrombotic therapy with early (<6-month post-PCI) intensified (low-dose ticagrelor [120 mg loading, then 60 mg bid maintenance] and aspirin) and late (>6-month post-PCI) deescalated (clopidogrel alone) strategy in patients undergoing high-risk complex PCI as compared with standard Dual Antiplatelet Therapy(aspirin and clopidogrel for 12 months).

Being tested
Tailored antithrombotic strategy, Conventional antithrombotic strategy
Keywords
antithrombotic strategy, dual antiplatelet therapy
Medical subject headings
Coronary Stenosis

What participants receive

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

  • Tailored antithrombotic strategyDrug

    Low-dose (60mg) ticagrelor + aspirin for 6months and then clopidogrel alone for 6months

  • Conventional antithrombotic strategyDrug

    Clopidogrel + aspirin for 12months

Study groups in NCT03465644
Study groupRoleWhat they receive
Tailored armExperimentalearly (<6-month post-PCI) intensified (low-dose ticagrelor [120 mg loading, then 60 mg bid maintenance] and aspirin) and late (>6-month post-PCI) deescalated (clopidogrel alone) strategy
Receives: Drug: Tailored antithrombotic strategy
Conventional armActive comparatorclopidogrel + aspirin for 12months
Receives: Drug: Conventional antithrombotic strategy

What is being measured

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

  1. Net clinical outcome

    a net clinical outcome of all-cause death, myocardial infarction, stroke, stent thrombosis, urgent revascularization or clinically relevant bleeding [Bleeding Academic Research Consortium (BARC) 2, 3, or 5] at 12 months after randomisation

    Measured: 1 year

Secondary outcomes (12)

  1. Death

    Efficacy outcomes: any, cardiovascular, or non-cardiovascular cause death

    Measured: 1 year

  2. Myocardial infarction

    Efficacy outcomes: any, periprocedural, or spontaneous Myocardial infarction

    Measured: 1 year

  3. Stroke

    Efficacy outcomes: any, ischemic, or hemorrhagic Stroke

    Measured: 1 year

  4. Stent thrombosis

    Efficacy outcomes

    Measured: 1 year

  5. The rate of unplanned urgent repeat revascularization

    Efficacy outcomes: any, target-vessel, or non-target-vessel Repeat revascularisation

    Measured: 1 year

  6. Composite of ischemic clinical endpoints (all-cause death, myocardial infarction, stroke, stent thrombosis, or urgent revascularization)

    Efficacy outcomes

    Measured: 1 year

  7. Composite of hard clinical endpoints (all-caused death, myocardial infarction, or stroke)

    Efficacy outcomes

    Measured: 1 year

  8. BARC major bleeding (type 3 or 5 bleeding)

    Safety outcomes: Bleeding Academic Research Consortium

    Measured: 1 year

  9. TIMI major or minor bleeding

    Safety outcomes: Thrombolysis In Myocardial Infarction

    Measured: 1 year

  10. GUSTO moderate or severe bleeding

    Safety outcomes: Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries

    Measured: 1 year

  11. ISTH major bleeding

    Safety outcomes: International Society of Thrombosis and Hemostasis; PCI, percutaneous coronary intervention

    Measured: 1 year

  12. Any major or minor bleeding

    Safety outcomes

    Measured: 1 year

Timeline

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

  1. First posted14 Mar 2018
  2. Study start12 Feb 2019
  3. Primary completion13 Feb 2025
  4. Study completion13 Feb 2025

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
2,018 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03465644
Sponsor's protocol ID
AMCCV2018-03
Acronym
TAILORED-CHIP
Status last verified
Jun 2025
First submitted
8 Mar 2018
Last updated
6 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Kang DY, Wee SB, Ahn JM, Park H, Yun SC, Park KH, Kang SH, Suh J, Bae JW, Park S, Cho JH, Suh JW, Lee BK, Rha SW, Won H, Jang JS, Cho YR, Lee CH, Ahn YK, Oh JH, Bae JS, Park CS, Lee JB, Choi J, Lee SW, Her SH, Kwon O, Park SJ, Park DW. Temporal modulation of antiplatelet therapy in high-risk patients undergoing complex percutaneous coronary intervention: the TAILORED-CHIP randomized clinical trial. Eur Heart J. 2026 May 5;47(17):2044-2055. doi: 10.1093/eurheartj/ehaf652.

    PubMed 40886179

  • Park H, Kang DY, Ahn JM, Yun SC, Park KH, Kang SH, Suh J, Bae JW, Park S, Cho JH, Suh JW, Lee BK, Rha SW, Won H, Jang JS, Kim MH, Lee CH, Ahn YK, Oh JH, Bae JS, Park CS, Choi J, Lee JB, Lee SW, Hur SH, Kwon O, Park SJ, Park DW, Tailored-Chip Trial Investigators OBOT. Temporal modulation (early escalation and late de-escalation) of antiplatelet therapy in patients undergoing complex high-risk PCI: rationale and design of the TAILORED-CHIP trial. EuroIntervention. 2024 Nov 4;20(21):e1355-e1362. doi: 10.4244/EIJ-D-24-00437.

    PubMed 39492701

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tailored antithrombotic strategy and Conventional antithrombotic strategy in people with Coronary Stenoses, run by Duk-Woo Park, MD at 22 sites 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 6 inclusion and 18 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: finished, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Net clinical outcome (time frame: 1 year). 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 NCT03465644, which also lists 2 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 6 Jun 2025.

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