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

NCT03465644 | Completed Phase 4 DMC

• 1 other identifier: AMCCV2018-03
• Study Type: interventional
• Target: 2,018
• Locations: 1 country
• Sites: 22

Brief 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 compared with standard Dual Antiplatelet Therapy(aspirin and clopidogrel for 12 months).

Conditions

Coronary Stenoses

Keywords

antithrombotic strategy; dual antiplatelet therapy

Outcome Measures

Primary Outcomes (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

  1 year

Secondary Outcomes (12)

• Death

  1 year

• Myocardial infarction

  1 year

• Stroke

  1 year

• Stent thrombosis

  1 year

• The rate of unplanned urgent repeat revascularization

  1 year

Study Arms (2)

Tailored arm

EXPERIMENTAL

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

Drug: Tailored antithrombotic strategy

Conventional arm

ACTIVE COMPARATOR

clopidogrel + aspirin for 12months

Drug: Conventional antithrombotic strategy

Interventions

Tailored antithrombotic strategy DRUG

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

Tailored arm

Conventional antithrombotic strategy DRUG

Clopidogrel + aspirin for 12months

Conventional arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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))
• 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.

Sponsors & Collaborators

• Duk-Woo Park, MD: lead
• CardioVascular Research Foundation, Korea: collaborator

Study Sites (22)

Hallym University Sacred Heart Hospital

Anyang, South Korea

Location

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, South Korea

Location

Gyeongsang National University Changwon Hospital

Changwon, South Korea

Location

Chungbuk National University Hospital

Cheonju, South Korea

Location

Gangwon National Univ. Hospital

Chuncheon, South Korea

Location

Daegu Catholic University Medical Center

Daegu, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

Gangneung Asan Hospital

Gangneung, South Korea

Location

Chonnam National University Hospital

Gwangju, South Korea

Location

Dong-A Medical Center

Pusan, South Korea

Location

Inje University Pusan Paik Hospital

Pusan, South Korea

Location

Pusan National University Hospital

Pusan, South Korea

Location

Bundang CHA Hospital

Seongnam, South Korea

Location

Seoul university Bundang hospital

Seongnam-si, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Chung-Ang University Hospital

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

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

Seoul, South Korea

Location

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

Seoul, South Korea

Location

St.Carollo Hospital

Suncheon, South Korea

Location

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

Suwon, South Korea

Location

Ulsan University Hospital

Ulsan, South Korea

Location

Related Publications (2)

• 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. 2025 Aug 31:ehaf652. doi: 10.1093/eurheartj/ehaf652. Online ahead of print.

  PMID: 40886179 DERIVED

• 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.

  PMID: 39492701 DERIVED

MeSH Terms

Conditions

Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Division of Cardiology

Study Record Dates

• First Submitted: March 8, 2018
• First Posted: March 14, 2018
• Study Start: February 12, 2019
• Primary Completion: February 13, 2025
• Study Completion: February 13, 2025
• Last Updated: June 6, 2025

Record last verified: 2025-06

Locations

KR (22)