Coronary Artery Disease Clinical Trial
— OPTIMIZE-APTOfficial title:
Tailored Versus Coventional AntiPlaTelet Strategy Intended After OPTIMIZEd Drug
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)
Status | Recruiting |
Enrollment | 3944 |
Est. completion date | December 31, 2028 |
Est. primary completion date | August 30, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | Inclusion Criteria: 1. Men or women =19 years 2. Typical chest pain or objective evidence of myocardial ischemia suitable for PCI 3. Significant de novo coronary artery lesions suitable for DES implantation 4. Patients who underwent optimized stent implantation either by IVUS or OCT - Using IVUS - MSA >5.5 mm2, or MSA >90% of the MLA at the distal reference segment - Plaque burden <50% with 5 mm of both stent edge - No edge dissection, thrombus or plaque protrusion/stent area <10% - Using OCT - MSA >4.5 mm2, or MSA >90% of the MLA at the distal reference segment - No significant malapposition - No significant edge dissection, thrombus or plaque protrusion/stent area <10% 5. 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: 1. Angiographic exclusion criteria: any of the followings 1. Bypass graft lesions 2. Lesions in which impaired delivery of imaging catheters is expected: - Extreme angulation (=90°) proximal to or within the target lesion. - Excessive tortuosity (= two 45° angles) proximal to or within the target lesion. - Heavy calcification proximal to or within the target lesion. 2. In-stent restenosis 3. 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. 4. Persistent thrombocytopenia (platelet count <80,000/l) 5. Any history of hemorrhagic stroke or intracranial hemorrhage / TIA or ischemic stroke within the past 6 months 6. A known intolerance or hypersensitivity to a study drug (aspirin, clopidogrel or ticagrelor) or heparin 7. Patients requiring long-term oral anticoagulants or cilostazol 8. Any surgery requiring general anesthesia or discontinuation of aspirin and/or an ADP antagonist is planned within 12 months after the procedure. 9. 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. 10. 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. 11. History of liver cirrhosis (Child-Pugh B or C) or biliary tract obstruction 12. Life expectancy < 1 years for any non-cardiac or cardiac causes 13. Cardiogenic shock at the index admission 14. Patient's pregnant or breast-feeding 15. 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) 16. Unwillingness or inability to comply with the procedures described in this protocol. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Bucheon Sejong Hospital | Bucheon | |
Korea, Republic of | Dong-A University Hospital | Busan | |
Korea, Republic of | Inje University Busan Paik Hospital | Busan | |
Korea, Republic of | Kosin University Gospel Hospital | Busan | |
Korea, Republic of | Gyeongsang National University Changwon Hospital | Changwon | |
Korea, Republic of | Kangwon National University Hospital | Chuncheon | |
Korea, Republic of | Chungbuk National University Hospital | Chungju | |
Korea, Republic of | Chungnam National University Sejong Hospital | Chungnam | |
Korea, Republic of | Dankook University Hospital | Chungnam | |
Korea, Republic of | Daegu Catholic Univ Medical Center | Daegu | |
Korea, Republic of | Keimyung University Dongsan Medical Center | Daegu | |
Korea, Republic of | Veterans Hospital | Daegu | |
Korea, Republic of | Gangneung Asan Hospital | Gangneung | |
Korea, Republic of | Jeonbuk National University Hospital | Jeonju | |
Korea, Republic of | Gyeongsang National University Hospital | Jinju | |
Korea, Republic of | Asan Medical Center | Seoul | |
Korea, Republic of | Kangbuk Samsung Hospital | Seoul | |
Korea, Republic of | Korea University Anam Hospital | Seoul | |
Korea, Republic of | The Catholic University of Korea, Eunpyeong St. Mary's Hospital | Seoul | |
Korea, Republic of | Veterans Hospital Service Medical Center | Seoul | |
Korea, Republic of | Ajou University Hospital | Suwon | |
Korea, Republic of | The Catholic University of Korea, ST. Vincent's Hospital | Suwon | |
Korea, Republic of | Ulsan University Hospital | Ulsan | |
Korea, Republic of | Pusan National University Yangsan Hospital | Yangsan |
Lead Sponsor | Collaborator |
---|---|
Asan Medical Center |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Secondary | 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 | |
Secondary | 2) % difference of strut coverage on FU OCT between optimal vs. suboptimal DES implantation group | 2) % difference of strut coverage on FU OCT between optimal vs. suboptimal DES implantation group | 1 or 3 month |
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