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

NCT ID: NCT03465644

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 2018 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-12
• Study Completion Date: 2025-02-13

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tailored arm

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

Group Type: EXPERIMENTAL

Tailored antithrombotic strategy

Intervention Type: DRUG

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

Conventional arm

clopidogrel + aspirin for 12months

Group Type: ACTIVE_COMPARATOR

Conventional antithrombotic strategy

Intervention Type: DRUG

Clopidogrel + aspirin for 12months

Interventions

Tailored antithrombotic strategy

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

Intervention Type: DRUG

Conventional antithrombotic strategy

Clopidogrel + aspirin for 12months

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age 19 and more

2. Subjects who scheduled for percutaneous coronary intervention(PCI) with contemporary drug-eluting stent

3. 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

4. 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.

Exclusion Criteria

1. Enzyme-positive Acute myocardial infarction (non-ST-elevation myocardial infarction (NSTEMI) or ST Elevation Myocardial Infarction (STEMI))

2. Contraindication to aspirin or P2Y12 inhibitors (ticagrelor or clopidogrel)

3. Use of Gp IIb/IIIa inhibitors at randomization

4. Cardiogenic shock

5. Treatment with only bare-metal stent (BMS) or balloon angioplasty during the index procedure.

6. Requirements for chronic oral anticoagulation (warfarin or Non-vitamin K antagonist oral anticoagulant (NOACs))

7. 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)

8. History of intracranial hemorrhage or intracranial aneurysm

9. Planned surgery within 180 days

10. Severe liver disease (ascites and/or coagulopathy) or Dialysis-dependent renal failure at screening

11. Platelet count <80,000 cells/mm3 or hemoglobin level <10 g/dL

12. At risk of bradycardia (subjects with sinus node dysfunction or atrioventricular block more than 2nd degree but without a permanent pacemaker)

13. 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

14. Pregnant and/or lactating women.

15. Concurrent medical condition with a life expectancy of less than 1 years

16. Active participation in another investigational study of a drug or device that has not completed the primary endpoint or follow-up period

17. Inability to provide written informed consent or participate in long-term follow-up

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CardioVascular Research Foundation, Korea

OTHER

Sponsor Role: collaborator

Duk-Woo Park, MD

OTHER

Sponsor Role: lead

Responsible Party

Duk-Woo Park, MD

Professor, Division of Cardiology

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Hallym University Sacred Heart Hospital

Anyang, , South Korea

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, , South Korea

Gyeongsang National University Changwon Hospital

Changwon, , South Korea

Chungbuk National University Hospital

Cheonju, , South Korea

Gangwon National Univ. Hospital

Chuncheon, , South Korea

Daegu Catholic University Medical Center

Daegu, , South Korea

Keimyung University Dongsan Medical Center

Daegu, , South Korea

Gangneung Asan Hospital

Gangneung, , South Korea

Chonnam National University Hospital

Gwangju, , South Korea

Dong-A Medical Center

Pusan, , South Korea

Inje University Pusan Paik Hospital

Pusan, , South Korea

Pusan National University Hospital

Pusan, , South Korea

Bundang CHA Hospital

Seongnam, , South Korea

Seoul university Bundang hospital

Seongnam-si, , South Korea

Asan Medical Center

Seoul, , South Korea

Chung-Ang University Hospital

Seoul, , South Korea

Korea University Guro Hospital

Seoul, , South Korea

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

Seoul, , South Korea

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

Seoul, , South Korea

St.Carollo Hospital

Suncheon, , South Korea

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

Suwon, , South Korea

Ulsan University Hospital

Ulsan, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 40886179 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39492701 (View on PubMed)

Other Identifiers

AMCCV2018-03

Identifier Type: -

Identifier Source: org_study_id