TAILored Versus COnventional AntithRombotic StratEgy IntenDed for Complex HIgh-Risk PCI (TAILORED-CHIP)

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).

Study Overview

• Status: Completed
• Conditions: Coronary Stenoses
• Intervention / Treatment: Drug: Tailored antithrombotic strategy; Drug: Conventional antithrombotic strategy

• Study Type: Interventional
• Enrollment (Actual): 2018
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Anyang, Korea, Republic of
    • Hallym University Sacred Heart Hospital
  • Bucheon, Korea, Republic of
    • Soon Chun Hyang University Hospital Bucheon
  • Changwon, Korea, Republic of
    • Gyeongsang National University Changwon Hospital
  • Cheonju, Korea, Republic of
    • Chungbuk National University Hospital
  • Chuncheon, Korea, Republic of
    • Gangwon National Univ. Hospital
  • Daegu, Korea, Republic of
    • Daegu Catholic University Medical Center
  • Daegu, Korea, Republic of
    • Keimyung University Dongsan Medical Center
  • Gangneung, Korea, Republic of
    • GangNeung Asan Hospital
  • Gwangju, Korea, Republic of
    • Chonnam National University Hospital
  • Pusan, Korea, Republic of
    • Pusan National University Hospital
  • Pusan, Korea, Republic of
    • Inje University Pusan Paik Hospital
  • Pusan, Korea, Republic of
    • Dong-A Medical Center
  • Seongnam, Korea, Republic of
    • Bundang CHA Hospital
  • Seongnam-si, Korea, Republic of
    • Seoul university Bundang hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Chung-Ang University Hospital
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of
    • The Catholic University of Korea, Yeouido St. Mary's Hospital
  • Seoul, Korea, Republic of
    • The Catholic Univ. of Korea Eunpyeong St. Mary's Hospital
  • Suncheon, Korea, Republic of
    • St.carollo Hospital
  • Suwon, Korea, Republic of
    • The Catholic University of Korea, St. Mary's Hospital
  • Ulsan, Korea, Republic of
    • Ulsan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Tailored antithrombotic strategy; Low-dose (60mg) ticagrelor + aspirin for 6months and then clopidogrel alone for 6months
Active Comparator: Conventional arm; clopidogrel + aspirin for 12months	Drug: Conventional antithrombotic strategy; Clopidogrel + aspirin for 12months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	Efficacy outcomes: any, cardiovascular, or non-cardiovascular cause death	1 year
Myocardial infarction	Efficacy outcomes: any, periprocedural, or spontaneous Myocardial infarction	1 year
Stroke	Efficacy outcomes: any, ischemic, or hemorrhagic Stroke	1 year
Stent thrombosis	Efficacy outcomes	1 year
Composite of ischemic clinical endpoints (all-cause death, myocardial infarction, stroke, stent thrombosis, or urgent revascularization)	Efficacy outcomes	1 year
Composite of hard clinical endpoints (all-caused death, myocardial infarction, or stroke)	Efficacy outcomes	1 year
BARC major bleeding (type 3 or 5 bleeding)	Safety outcomes: Bleeding Academic Research Consortium	1 year
TIMI major or minor bleeding	Safety outcomes: Thrombolysis In Myocardial Infarction	1 year
GUSTO moderate or severe bleeding	Safety outcomes: Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries	1 year
ISTH major bleeding	Safety outcomes: International Society of Thrombosis and Hemostasis; PCI, percutaneous coronary intervention	1 year
Any major or minor bleeding	Safety outcomes	1 year
The rate of unplanned urgent repeat revascularization	Efficacy outcomes: any, target-vessel, or non-target-vessel Repeat revascularisation	1 year

Collaborators and Investigators

• Sponsor: Duk-Woo Park, MD
• Collaborators: CardioVascular Research Foundation, Korea

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2019
• Primary Completion (Actual): February 13, 2025
• Study Completion (Actual): February 13, 2025

Study Registration Dates

• First Submitted: March 8, 2018
• First Submitted That Met QC Criteria: March 8, 2018
• First Posted (Actual): March 14, 2018

Study Record Updates

• Last Update Posted (Actual): June 6, 2025
• Last Update Submitted That Met QC Criteria: June 4, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: dual antiplatelet therapy; antithrombotic strategy
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Coronary Disease; Myocardial Ischemia; Coronary Stenosis
• Other Study ID Numbers: AMCCV2018-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No