Tailored Versus Coventional AntiPlaTelet Strategy Intended After OPTIMIZEd Drug Eluting Stent

Recruiting now · Phase 4

Conditions studied: Coronary Artery Disease

In brief

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)

Key facts

Study ID

NCT05418556

Run by

Asan Medical Center

People needed

3944

Starts

2022-10-21

Expected to finish

2032-12-31

Last updated by the study team

2026-06-25

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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%
• 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

You may not qualify if…

• 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.
• 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.

Where it is running

• Bucheon Sejong Hospital — Bucheon-si, South Korea (enrolling)
• Dong-A University Hospital — Busan, South Korea (enrolling)
• Chungnam National University Sejong Hospital — Jungnam, South Korea (enrolling)
• Dankook University Hospital — Jungnam, South Korea (enrolling)
• Asan Medical Center — Seoul, South Korea (enrolling)
• Kangbuk Samsung Hospital — Seoul, South Korea (enrolling)
• Korea University Anam Hospital — Seoul, South Korea (enrolling)
• The Catholic University of Korea, Eunpyeong St. Mary's Hospital — Seoul, South Korea (enrolling)
• Veterans Hospital Service Medical Center — Seoul, South Korea (enrolling)
• Ajou University Hospital — Suwon, South Korea (enrolling)
• Ulsan University Hospital — Ulsan, South Korea (enrolling)
• Kosin University Gospel Hospital — Busan, South Korea (enrolling)
• Gyeongsang National University Changwon Hospital — Changwon, South Korea (enrolling)
• Kangwon National University Hospital — Chuncheon, South Korea (enrolling)
• Chungbuk National University Hospital — Chungju, South Korea (enrolling)
• Keimyung University Dongsan Medical Center — Daegu, South Korea (enrolling)
• Kyungpook National University Hospital — Daegu, South Korea (enrolling)
• Veterans Hospital — Daegu, South Korea (enrolling)
• The Catholic University of Korea, Daejeon ST. Mary's Hospital — Daejeon, South Korea (enrolling)
• Gangneung Asan Hospital — Gangneung, South Korea (enrolling)
• Jeju National University Hospital — Jeju City, South Korea (enrolling)
• Jeonbuk National University Hospital — Jeonju, South Korea (enrolling)
• Gyeongsang National University Hospital — Jinju, South Korea (enrolling)
• Chungnam National University Hospital — Jungnam, South Korea (enrolling)
• Inje University Busan Paik Hospital — Busan, South Korea

Full record on ClinicalTrials.gov

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