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Recruiting Phase 4

OPTIMIZE-APT: Tailored Versus Conventional Antiplatelet Therapy After Intravascular Imaging-guided Drug-eluting Stent Implantation

NCT05418556 · tracked via the Priya Life Science South Korea tracker
Phase
Phase 4
Started
2022-10-21
Last updated
2026-09-17

Condition(s) studied

Coronary Artery Disease

Investigational drug(s) / intervention(s)

aspirin →

aspirin: DAPT strategy

Study summary

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)

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
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 occupying \< 10% of the stent area * 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 occupying \< 10% of the stent area (\*Significant malapposition is defined as strut separation ≥ 0.3 mm from the vessel wall extending over a length \> 3 mm. †Significant dissection is defined as a dissection penetrating the medial layer and extending over more than one quadrant.) 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/μl) 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.

Primary outcome measure(s)

  • Composite ischemic endpoint — 12 month
    Ischemic composite adverse event of all-cause death, myocardial infarction (MI), ischemia-driven target vessel revascularization (TVR), definite/probable stent thrombosis (ST)
  • Net adverse clinical events (NACE) — 12 month
    Net clinical outcome defined as a composite of all-cause death, myocardial infarction (MI), ischemia-driven target vessel revascularization (TVR), definite/probable stent thrombosis (ST), and clinically relevant bleeding \[BARC 2, 3, or 5\]
  • Clinically relevant bleeding — 12 month
    Clinically relevant bleeding \[Bleeding Academic Research Consortium (BARC) 2, 3, or 5\]

Trial sites (33)

FacilityCityRegionStatus
Bucheon Sejong Hospital Bucheon-si South Korea Recruiting
Dong-A University Hospital Busan South Korea Recruiting
Inje University Busan Paik Hospital Busan South Korea Not Yet Recruiting
Inje University Haeundae Paik Hospital Busan South Korea Not Yet Recruiting
Kosin University Gospel Hospital Busan South Korea Recruiting
Gyeongsang National University Changwon Hospital Changwon South Korea Recruiting
Kangwon National University Hospital Chuncheon South Korea Recruiting
Chungbuk National University Hospital Chungju South Korea Recruiting
Daegu Catholic Univ Medical Center Daegu South Korea Not Yet Recruiting
Keimyung University Dongsan Medical Center Daegu South Korea Recruiting
Kyungpook National University Hospital Daegu South Korea Recruiting
Veterans Hospital Daegu South Korea Recruiting
The Catholic University of Korea, Daejeon ST. Mary's Hospital Daejeon South Korea Recruiting
Gangneung Asan Hospital Gangneung South Korea Recruiting
Hallym Univ. Medical Center. Hwaseong-si South Korea Not Yet Recruiting
dongguk University Medical Center Ilsan South Korea Not Yet Recruiting
Jeju National University Hospital Jeju City South Korea Recruiting
Jeonbuk National University Hospital Jeonju South Korea Recruiting
Gyeongsang National University Hospital Jinju South Korea Recruiting
Chungnam National University Hospital Jungnam South Korea Recruiting
Chungnam National University Sejong Hospital Jungnam South Korea Recruiting
Dankook University Hospital Jungnam South Korea Recruiting
Asan Medical Center Seoul South Korea Recruiting
Kangbuk Samsung Hospital Seoul South Korea Recruiting
Korea University Anam Hospital Seoul South Korea Recruiting
The Catholic University of Korea, Eunpyeong St. Mary's Hospital Seoul South Korea Recruiting
Veterans Hospital Service Medical Center Seoul South Korea Recruiting
Ajou University Hospital Suwon South Korea Recruiting
The Catholic University of Korea, ST. Vincent's Hospital Suwon South Korea Completed
The Catholic University of Korea, Uijeongbu ST. Mary's Hospital Uijeongbu-si South Korea Not Yet Recruiting
Dongkang Hospital Ulsan South Korea Not Yet Recruiting
Ulsan University Hospital Ulsan South Korea Recruiting
Pusan National University Yangsan Hospital Yangsan South Korea Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05418556 on ClinicalTrials.gov ↗ ← All trials in South Korea