TAILored Versus COnventional AntithRombotic StratEgy IntenDed for Complex HIgh-Risk PCI (TAILORED-CHIP)
Primary Purpose
Coronary Stenoses
Status
Recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tailored antithrombotic strategy
Conventional antithrombotic strategy
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Stenoses focused on measuring antithrombotic strategy, dual antiplatelet therapy
Eligibility Criteria
Inclusion Criteria:
- Age 19 and more
- Subjects who scheduled for percutaneous coronary intervention(PCI) with contemporary drug-eluting stent
- at least one of the following high-risk clinical, lesion or procedure-related risk 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
Exclusion Criteria:
- Enzyme-positive ACS (NSTEMI or STEMI)
- Contraindication to aspirin or P2Y12 inhibitors (ticagrelor or clopidogrel)
- Cardiogenic shock at the index admission
- Treated with only bare metal stent or balloon angioplasty during the index procedure
- Need for chronic oral anticoagulation
- 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 haemorrhage or intracranial aneurysm
- Planned surgery within 180 days
- Liver cirrhosis
- Dialysis-dependent renal failure
- Pregnant and/or lactating women
- Concurrent medical condition with a life expectancy of less than 1 years
- Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period
- Unable to provide written informed consent or participate in long-term follow-up
Sites / Locations
- Hallym University Sacred Heart HospitalRecruiting
- Soon Chun Hyang University Hospital BucheonRecruiting
- Gyeongsang National University Changwon HospitalRecruiting
- Soonchunhyang University Hospital, Cheonan
- Chungbuk National University HospitalRecruiting
- Gangwon National Univ. HospitalRecruiting
- Daegu Catholic University Medical CenterRecruiting
- Keimyung University Dongsan Medical Center
- Yeungnam University Medical Center
- Gangneung Asan HospitalRecruiting
- Chonnam National University HospitalRecruiting
- Dong-A Medical CenterRecruiting
- Inje University Pusan Paik HospitalRecruiting
- Pusan National University Hospital
- Seoul university Bundang hospitalRecruiting
- Bundang CHA HospitalRecruiting
- Asan Medical CenterRecruiting
- Chung-Ang University Hospital
- Eulji Medical Center, Eulji University
- Korea University Guro HospitalRecruiting
- The Catholic Univ. of Korea Eunpyeong St. Mary's hospitalRecruiting
- The Catholic University of Korea, Yeouido St. Mary's HospitalRecruiting
- St.Carollo HospitalRecruiting
- The Catholic University of Korea, ST. Mary's HospitalRecruiting
- Ulsan University HospitalRecruiting
- Wonju Severance Christian Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tailored arm
Conventional arm
Arm Description
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
clopidogrel + aspirin for 12months
Outcomes
Primary Outcome Measures
Net clinical outcome
a net clinical outcome of all-cause death, MI, stroke, stent thrombosis, urgent revascularization and clinically relevant bleeding [Bleeding Academic Research Consortium (BARC) 2, 3, or 5] at 12 months post-PCI.
Secondary Outcome Measures
All-cause death
Myocardial infarction
Stroke
Stent thrombosis
Urgent revascularization
Clinically relevant bleeding
Bleeding Academic Research Consortium (BARC) 2, 3, or 5
Composite of death (all or cardiovascular), MI, or stroke, stent thrombosis or urgent revascularization
Composite of death (all or cardiovascular), MI, or stroke
Composite of death (all or cardiovascular) or MI
Any revascularization
BARC type 3 or 5 bleeding
Major or minor bleeding according to definitions from The Thrombolysis in Myocardial Infarction (TIMI)
Major or minor bleeding according to definitions from International Society of Thrombosis or Hemostasis (ISTH)
Full Information
NCT ID
NCT03465644
First Posted
March 8, 2018
Last Updated
April 5, 2023
Sponsor
Duk-Woo Park, MD
Collaborators
CardioVascular Research Foundation, Korea
1. Study Identification
Unique Protocol Identification Number
NCT03465644
Brief Title
TAILored Versus COnventional AntithRombotic StratEgy IntenDed for Complex HIgh-Risk PCI
Acronym
TAILORED-CHIP
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 12, 2019 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Duk-Woo Park, MD
Collaborators
CardioVascular Research Foundation, Korea
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Stenoses
Keywords
antithrombotic strategy, dual antiplatelet therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tailored arm
Arm Type
Experimental
Arm Description
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
Arm Title
Conventional arm
Arm Type
Active Comparator
Arm Description
clopidogrel + aspirin for 12months
Intervention Type
Drug
Intervention Name(s)
Tailored antithrombotic strategy
Intervention Description
Low-dose (60mg) ticagrelor + aspirin for 6months and then clopidogrel alone for 6months
Intervention Type
Drug
Intervention Name(s)
Conventional antithrombotic strategy
Intervention Description
Clopidogrel + aspirin for 12months
Primary Outcome Measure Information:
Title
Net clinical outcome
Description
a net clinical outcome of all-cause death, MI, stroke, stent thrombosis, urgent revascularization and clinically relevant bleeding [Bleeding Academic Research Consortium (BARC) 2, 3, or 5] at 12 months post-PCI.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
All-cause death
Time Frame
1 year
Title
Myocardial infarction
Time Frame
1 year
Title
Stroke
Time Frame
1 year
Title
Stent thrombosis
Time Frame
1 year
Title
Urgent revascularization
Time Frame
1 year
Title
Clinically relevant bleeding
Description
Bleeding Academic Research Consortium (BARC) 2, 3, or 5
Time Frame
1 year
Title
Composite of death (all or cardiovascular), MI, or stroke, stent thrombosis or urgent revascularization
Time Frame
1 year
Title
Composite of death (all or cardiovascular), MI, or stroke
Time Frame
1 year
Title
Composite of death (all or cardiovascular) or MI
Time Frame
1 year
Title
Any revascularization
Time Frame
1 year
Title
BARC type 3 or 5 bleeding
Time Frame
1 year
Title
Major or minor bleeding according to definitions from The Thrombolysis in Myocardial Infarction (TIMI)
Time Frame
1 year
Title
Major or minor bleeding according to definitions from International Society of Thrombosis or Hemostasis (ISTH)
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 19 and more
Subjects who scheduled for percutaneous coronary intervention(PCI) with contemporary drug-eluting stent
at least one of the following high-risk clinical, lesion or procedure-related risk 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
Exclusion Criteria:
Enzyme-positive ACS (NSTEMI or STEMI)
Contraindication to aspirin or P2Y12 inhibitors (ticagrelor or clopidogrel)
Cardiogenic shock at the index admission
Treated with only bare metal stent or balloon angioplasty during the index procedure
Need for chronic oral anticoagulation
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 haemorrhage or intracranial aneurysm
Planned surgery within 180 days
Liver cirrhosis
Dialysis-dependent renal failure
Pregnant and/or lactating women
Concurrent medical condition with a life expectancy of less than 1 years
Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period
Unable to provide written informed consent or participate in long-term follow-up
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Duk-woo Park, MD
Email
dwpark@amc.seoul.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Jung-hee Ham, Project Manager
Email
cvcrc5@amc.seoul.kr
Facility Information:
Facility Name
Hallym University Sacred Heart Hospital
City
Anyang
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyoung-ha Park, MD
Email
pkhmd@naver.com
First Name & Middle Initial & Last Name & Degree
Kyoung-ha Park, MD
Facility Name
Soon Chun Hyang University Hospital Bucheon
City
Bucheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jon Suh, MD
Email
immanuel@schmc.ac.kr
First Name & Middle Initial & Last Name & Degree
Jon Suh, MD
Facility Name
Gyeongsang National University Changwon Hospital
City
Changwon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae-seok Bae, MD
First Name & Middle Initial & Last Name & Degree
Jae-seok Bae, MD
Facility Name
Soonchunhyang University Hospital, Cheonan
City
Cheonan
Country
Korea, Republic of
Individual Site Status
Withdrawn
Facility Name
Chungbuk National University Hospital
City
Cheonju
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jang-hwan Bae, MD
First Name & Middle Initial & Last Name & Degree
Jang-hwan Bae, MD
Facility Name
Gangwon National Univ. Hospital
City
Chuncheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bong-ki Lee, MD
Email
mdbklee@kangwon.ac.kr
First Name & Middle Initial & Last Name & Degree
Bong-ki Lee, MD
Facility Name
Daegu Catholic University Medical Center
City
Daegu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin-bae Lee, MD
Email
jblee@cu.ac.kr
First Name & Middle Initial & Last Name & Degree
Jin-bae Lee, MD
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chul-hyun Lee, MD
First Name & Middle Initial & Last Name & Degree
Chul-hyun Lee, MD
Facility Name
Yeungnam University Medical Center
City
Daegu
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Woong Kim, MD
Email
woongwa@yu.ac.kr
First Name & Middle Initial & Last Name & Degree
Woong Kim, MD
Facility Name
Gangneung Asan Hospital
City
Gangneung
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Han-bit Park, MD
First Name & Middle Initial & Last Name & Degree
Han-bit Park, MD
Facility Name
Chonnam National University Hospital
City
Gwangju
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young-keun Ahn, MD
Email
cecilyk@chonnam.ac.kr
First Name & Middle Initial & Last Name & Degree
Young-keun Ahn, MD
Facility Name
Dong-A Medical Center
City
Pusan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moo-hyun Kim, MD
Email
kmh60@damc.or.kr
First Name & Middle Initial & Last Name & Degree
Moo-hyun Kim, MD
Facility Name
Inje University Pusan Paik Hospital
City
Pusan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae-sik Jang, MD
Email
jsjang@medimail.co.kr
First Name & Middle Initial & Last Name & Degree
Jae-sik Jang, MD
Facility Name
Pusan National University Hospital
City
Pusan
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joon-hyuk Oh, MD
First Name & Middle Initial & Last Name & Degree
Joon-hyuk Oh, MD
Facility Name
Seoul university Bundang hospital
City
Seongnam-si
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jung-won Suh, MD
Email
suhjw1@gmail.com
First Name & Middle Initial & Last Name & Degree
Jung-won Suh, MD
Facility Name
Bundang CHA Hospital
City
Seongnam
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Se-hun Kang, MD
First Name & Middle Initial & Last Name & Degree
Se-hun Kang, MD
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Duk-woo Park, MD
Email
dwpark@amc.seoul.kr
First Name & Middle Initial & Last Name & Degree
Duk-woo Park, MD
Facility Name
Chung-Ang University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ho-yeon Won, MD
First Name & Middle Initial & Last Name & Degree
Ho-yeon Won, MD
Facility Name
Eulji Medical Center, Eulji University
City
Seoul
Country
Korea, Republic of
Individual Site Status
Withdrawn
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seung-woon Rha, MD
Email
swrha617@yahoo.co.kr
First Name & Middle Initial & Last Name & Degree
Seung-woon Rha, MD
Facility Name
The Catholic Univ. of Korea Eunpyeong St. Mary's hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
o-sung Kwon, MD
First Name & Middle Initial & Last Name & Degree
o-sung Kwon, MD
Facility Name
The Catholic University of Korea, Yeouido St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chul-soo Park, MD
Email
charlie@catholic.ac.kr
First Name & Middle Initial & Last Name & Degree
Chul-soo Park, MD
Facility Name
St.Carollo Hospital
City
Suncheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jang-hyun Cho, MD
Email
goodnew8@naver.com
First Name & Middle Initial & Last Name & Degree
Jang-hyun Cho, MD
Facility Name
The Catholic University of Korea, ST. Mary's Hospital
City
Suwon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung-ho Her, MD
First Name & Middle Initial & Last Name & Degree
Sung-ho Her, MD
Facility Name
Ulsan University Hospital
City
Ulsan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang-woo Park, MD
First Name & Middle Initial & Last Name & Degree
Sang-woo Park, MD
Facility Name
Wonju Severance Christian Hospital
City
Wonju
Country
Korea, Republic of
Individual Site Status
Withdrawn
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
TAILored Versus COnventional AntithRombotic StratEgy IntenDed for Complex HIgh-Risk PCI
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