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Objectives: To assess the safety of tailored antiplatelet therapy (short DAPT followed by P2Y12 inhibitor alone strategy) in patients who received optimized DES implantation guided by intravascular imaging (IVUS or OCT)
Hypothesis: Tailored antiplatelet strategy (short DAPT followed by P2Y12 inhibitor alone) is superior to conventional antiplatelet strategy in terms of clinically relevant bleeding and noninferior for ischemic composite adverse events in patients who received intravascular imaging-guided optimized DES implantation. (Optimized stent evaluated by on-site IVUS/OCT could act as an essential criterion for decision making for tailored antithrombotic strategy)
Objective: To assess the safety of tailored antiplatelet strategy (short DAPT followed by P2Y12 inhibitor alone) in patients who received optimized DES implantation guided by intravascular imaging (IVUS or OCT)
Design: Prospective, open label, multi-center, dual arm, randomized trial Number of Subjects 3,944 subjects (1972:1972) Study Population: Patients with coronary artery disease undergoing imaging-guided PCI
Study Design:
Co-primary Endpoints:
Statistics and Analysis: The study was designed to test the hypothesis that tailored antithrombotic strategy, as compared to the conventional DAPT, would be superior for clinically relevant bleeding, noninferior to the ischemic composite adverse events and NACE. The primary analysis would be evaluated by intention-to-treat analysis. With 3756 (each 1,878) patients, this study has >80% power to detect noninferiority of tailored antiplatelet strategy for ischemic composite adverse event, >85% power to detect noninferiority of tailored antiplatelet strategy for NACE, and >85% power to detect superiority of the tailored antiplatelet arm on clinically relevant bleeding. To compensate for 5% attrition rate, 3,944 (each 1,972) patients will be randomized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Arm | Active Comparator | The antiplatelet regimens Post-PCI are at least 6-month DAPT (aspirin plus clopidogrel) for CCS, and at least-12month DAPT (aspirin plus P2Y12 inhibitor [Ticagrelor, prasugrel]) for ACS. |
|
| Tailored Arm | Experimental | The antiplatelet regimens post-PCI are 1-month DAPT (aspirin plus clopidogrel) followed by 11-months clopidogrel alone for CCS, and 3-months DAPT (aspirin plus P2Y12 inhibitor [ticagrelor, prasugrel]) followed by 9-months P2Y12 inhibitor alone for ACS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aspirin | Drug | DAPT strategy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1) clinically relevant bleeding [Bleeding Academic Research Consortium (BARC) 2, 3, or 5] | 1) clinically relevant bleeding [Bleeding Academic Research Consortium (BARC) 2, 3, or 5] | 12 month |
| 2) net clinical outcome defined as a composite of all-cause death, MI, ischemia-driven target vessel revascularization (TVR), definite/probable stent thrombosis (ST), and clinically relevant bleeding [BARC 2, 3, or 5] | 2) net clinical outcome defined as a composite of all-cause death, MI, ischemia-driven target vessel revascularization (TVR), definite/probable stent thrombosis (ST), and clinically relevant bleeding [BARC 2, 3, or 5] | 12 month |
| 3) ischemic composite adverse event of all-cause death, MI, ischemia-driven target vessel revascularization (TVR), definite/probable stent thrombosis (ST) | 3) ischemic composite adverse event of all-cause death, MI, ischemia-driven target vessel revascularization (TVR), definite/probable stent thrombosis (ST) | 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| 1) Major or minor bleeding according to definitions from TIMI and International Society of Thrombosis or Hemostasis (ISTH) | 1) Major or minor bleeding according to definitions from TIMI and International Society of Thrombosis or Hemostasis (ISTH) | 12 month |
| 2) % difference of strut coverage on FU OCT between optimal vs. suboptimal DES implantation group |
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Inclusion Criteria:
Men or women ≥19 years
Typical chest pain or objective evidence of myocardial ischemia suitable for PCI
Significant de novo coronary artery lesions suitable for DES implantation
Patients who underwent optimized stent implantation either by IVUS or OCT
Using IVUS
Using OCT
The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site
Exclusion Criteria:
Angiographic exclusion criteria: any of the followings 1. Bypass graft lesions 2. Lesions in which impaired delivery of imaging catheters is expected:
In-stent restenosis
Hypersensitivity or contraindication to device material and its degradants and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated.
Persistent thrombocytopenia (platelet count <80,000/l)
Any history of hemorrhagic stroke or intracranial hemorrhage / TIA or ischemic stroke within the past 6 months
A known intolerance or hypersensitivity to a study drug (aspirin, clopidogrel or ticagrelor) or heparin
Patients requiring long-term oral anticoagulants or cilostazol
Any surgery requiring general anesthesia or discontinuation of aspirin and/or an ADP antagonist is planned within 12 months after the procedure.
A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer.
Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study.
History of liver cirrhosis (Child-Pugh B or C) or biliary tract obstruction
Life expectancy < 1 years for any non-cardiac or cardiac causes
Cardiogenic shock at the index admission
Patient's pregnant or breast-feeding
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)
Unwillingness or inability to comply with the procedures described in this protocol.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ji Sue Hong, RN | Contact | 82 2-2045-3798 | sue5165@naver.com | |
| Pil Hyung Lee, MD | Contact | 82 2-3010-3170 | pilmo11@hanmail.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bucheon Sejong Hospital | Recruiting | Bucheon-si | South Korea |
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2) % difference of strut coverage on FU OCT between optimal vs. suboptimal DES implantation group |
| 1 or 3 month |
| Dong-A University Hospital | Recruiting | Busan | South Korea |
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| Inje University Busan Paik Hospital | Not yet recruiting | Busan | South Korea |
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| Inje University Haeundae Paik Hospital | Not yet recruiting | Busan | South Korea |
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| Kosin University Gospel Hospital | Recruiting | Busan | South Korea |
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| Gyeongsang National University Changwon Hospital | Recruiting | Changwon | South Korea |
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| Kangwon National University Hospital | Recruiting | Chuncheon | South Korea |
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| Chungbuk National University Hospital | Recruiting | Chungju | South Korea |
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| Daegu Catholic Univ Medical Center | Not yet recruiting | Daegu | South Korea |
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| Keimyung University Dongsan Medical Center | Recruiting | Daegu | South Korea |
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| Kyungpook National University Hospital | Recruiting | Daegu | South Korea |
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| Veterans Hospital | Recruiting | Daegu | South Korea |
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| The Catholic University of Korea, Daejeon ST. Mary's Hospital | Recruiting | Daejeon | South Korea |
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| Gangneung Asan Hospital | Recruiting | Gangneung | South Korea |
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| Hallym Univ. Medical Center. | Not yet recruiting | Hwaseong-si | South Korea |
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| dongguk University Medical Center | Not yet recruiting | Ilsan | South Korea |
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| Jeju National University Hospital | Recruiting | Jeju City | South Korea |
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| Jeonbuk National University Hospital | Recruiting | Jeonju | South Korea |
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| Gyeongsang National University Hospital | Recruiting | Jinju | South Korea |
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| Chungnam National University Hospital | Recruiting | Jungnam | South Korea |
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| Chungnam National University Sejong Hospital | Recruiting | Jungnam | South Korea |
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| Dankook University Hospital | Recruiting | Jungnam | South Korea |
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| Asan Medical Center | Recruiting | Seoul | South Korea |
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| Kangbuk Samsung Hospital | Recruiting | Seoul | South Korea |
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| Korea University Anam Hospital | Recruiting | Seoul | South Korea |
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| The Catholic University of Korea, Eunpyeong St. Mary's Hospital | Recruiting | Seoul | South Korea |
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| Veterans Hospital Service Medical Center | Recruiting | Seoul | South Korea |
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| Ajou University Hospital | Recruiting | Suwon | South Korea |
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| The Catholic University of Korea, ST. Vincent's Hospital | Completed | Suwon | South Korea |
| The Catholic University of Korea, Uijeongbu ST. Mary's Hospital | Not yet recruiting | Uijeongbu-si | South Korea |
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| Dongkang Hospital | Not yet recruiting | Ulsan | South Korea |
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| Ulsan University Hospital | Recruiting | Ulsan | South Korea |
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| Pusan National University Yangsan Hospital | Not yet recruiting | Yangsan | South Korea |
|
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| D000077144 | Clopidogrel |
| D000068799 | Prasugrel Hydrochloride |
| D000077486 | Ticagrelor |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010879 | Piperazines |
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
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