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

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)

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: aspirin

Detailed Description

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:

• Eligible subjects will be randomized 1:1 to a) conventional DAPT strategy or b) tailored anti-platelet strategy (short DAPT followed by P2Y12 inhibitor alone) after optimized DES implantation guided by intravascular imaging.
• All subjects will be clinically followed at 1(or 3), 6, and 12, 18, 24, 36, 48, 50 months

Co-primary Endpoints:

1. Ischemic composite of all-cause death, myocardial infarction, ischemia-driven target-vessel revascularization, and definite or probable stent thrombosis at 12 months post-PCI
2. Net adverse clinical events, defined as the ischemic composite plus clinically relevant bleeding at 12 months post-PCI
3. Clinically relevant bleeding, defined as Bleeding Academic Research Consortium type 2, 3, or 5 bleeding at 12 months post-PCI

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.

• Study Type: Interventional
• Enrollment (Estimated): 3944
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ji Sue Hong, RN; Phone Number: 82 2-2045-3798; Email: sue5165@naver.com
• Study Contact Backup: Name: Seung-Whan Lee, MD; Phone Number: 82 2-3010-3170; Email: seungwlee@amc.seoul.kr

Study Locations

• South Korea
  • Bucheon-si, South Korea
    • Recruiting
    • Bucheon Sejong Hospital
    • Contact: Ha Wook Park, MD
    • Principal Investigator: Ha Wook Park, MD
  • Busan, South Korea
    • Recruiting
    • Dong-A University Hospital
    • Contact: Yong Rak Cho, MD
    • Principal Investigator: Yong Rak Cho, MD
  • Busan, South Korea
    • Recruiting
    • Kosin University Gospel Hospital
    • Principal Investigator: Jeong Ho Heo, MD
    • Contact: Jeong Ho Heo, MD
  • Busan, South Korea
    • Not yet recruiting
    • Inje University Busan Paik Hospital
    • Contact: Tae Hyun Yang, MD
    • Principal Investigator: Tae Hyun Yang, MD
  • Busan, South Korea
    • Not yet recruiting
    • Inje University Haeundae Paik Hospital
    • Contact: Dongk-kie Kim, MD
    • Principal Investigator: Dongk-kie Kim, MD
  • Changwon, South Korea
    • Recruiting
    • Gyeongsang National University Changwon Hospital
    • Principal Investigator: Jae Seok Bae, MD
    • Contact: Jae Seok Bae, MD
  • Chuncheon, South Korea
    • Recruiting
    • Kangwon National University Hospital
    • Contact: Bong Ki Lee, MD
    • Principal Investigator: Bong Ki Lee, MD
  • Chungju, South Korea
    • Recruiting
    • Chungbuk National University Hospital
    • Contact: Sang Min Kim, MD
    • Principal Investigator: Sang Min Kim, MD
  • Daegu, South Korea
    • Recruiting
    • Keimyung University Dongsan Medical Center
    • Principal Investigator: Hyuck jun yoon, MD
    • Contact: Hyuck jun yoon, MD
  • Daegu, South Korea
    • Recruiting
    • Kyungpook National University Hospital
    • Contact: NAM KYUN KIM, MD
    • Principal Investigator: Nam kyun Kim, MD
  • Daegu, South Korea
    • Recruiting
    • Veterans Hospital
    • Contact: Sang Wook Kang, MD
    • Principal Investigator: Sang Wook Kang, MD
  • Daegu, South Korea
    • Not yet recruiting
    • Daegu Catholic Univ Medical Center
    • Contact: Jin Bae Lee, MD
    • Principal Investigator: Jin Bae Lee, MD
  • Daejeon, South Korea
    • Recruiting
    • The Catholic University of Korea, Daejeon ST. Mary's Hospital
    • Principal Investigator: Kyusup Lee, MD
    • Contact: Kyusup Lee, MD
  • Gangneung, South Korea
    • Recruiting
    • Gangneung Asan Hospital
    • Contact: Han Bit Park, MD
    • Principal Investigator: Han Bit Park, MD
  • Hwaseong-si, South Korea
    • Not yet recruiting
    • Hallym Univ. Medical Center.
    • Contact: Jeen Hwa Lee, MD
    • Principal Investigator: Jeen Hwa Lee, MD
  • Ilsan, South Korea
    • Not yet recruiting
    • dongguk University Medical Center
    • Contact: Jae sik Jang, MD
    • Principal Investigator: Jae sik Jang, MD
  • Jeju City, South Korea
    • Recruiting
    • Jeju National University Hospital
    • Contact: Joon Hyouk Choi, MD
    • Principal Investigator: Joon Hyouk Choi, MD
  • Jeonju, South Korea
    • Recruiting
    • Jeonbuk National University Hospital
    • Contact: Yisik Kim, MD
    • Principal Investigator: Yisik Kim, MD
  • Jinju, South Korea
    • Recruiting
    • Gyeongsang National University Hospital
    • Contact: Jin Sin Koh, MD
    • Principal Investigator: Jin Sin Koh, MD
  • Jungnam, South Korea
    • Recruiting
    • Chungnam National University Sejong Hospital
    • Contact: Won mook Hwang, MD
    • Principal Investigator: Won mook Hwang, MD
  • Jungnam, South Korea
    • Recruiting
    • Dankook University Hospital
    • Contact: tae soo kang, MD
    • Principal Investigator: tae soo kang, MD
  • Jungnam, South Korea
    • Recruiting
    • Chungnam National University Hospital
    • Contact: Jae Hwan Lee, MD
    • Principal Investigator: Jae Hwan Lee, MD
  • Seoul, South Korea
    • Recruiting
    • Asan Medical Center
    • Contact: Seung-Whan Lee, MD; Email: seungwlee@amc.seoul.kr
    • Principal Investigator: Seung-Whan Lee, MD
    • Sub-Investigator: Tae Oh Kim, MD
  • Seoul, South Korea
    • Recruiting
    • The Catholic University of Korea, Eunpyeong St. Mary's Hospital
    • Contact: Pum Joon Kim, MD
    • Principal Investigator: Pum Joon Kim, MD
  • Seoul, South Korea
    • Recruiting
    • Korea University Anam Hospital
    • Contact: Soon Jun Hong, MD
    • Principal Investigator: Soon Jun Hong, MD
  • Seoul, South Korea
    • Recruiting
    • Kangbuk Samsung Hospital
    • Contact: seung jae Lee, MD
    • Principal Investigator: seung jae Lee, MD
  • Seoul, South Korea
    • Recruiting
    • Veterans Hospital Service Medical Center
    • Contact: Chang Hoon Lee, MD
    • Principal Investigator: Chang Hoon Lee, MD
  • Suwon, South Korea
    • Recruiting
    • Ajou University Hospital
    • Contact: Myeong Ho Yoon, MD
    • Principal Investigator: Myeong Ho Yoon, MD
  • Suwon, South Korea
    • Completed
    • The Catholic University of Korea, St. Vincent's Hospital
  • Uijeongbu-si, South Korea
    • Not yet recruiting
    • The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
    • Contact: Chan Joon Kim, MD
    • Principal Investigator: Chan Joon Kim, MD
  • Ulsan, South Korea
    • Recruiting
    • Ulsan University Hospital
    • Contact: Gyung Min Park, MD
    • Principal Investigator: Gyung Min Park, MD
  • Ulsan, South Korea
    • Not yet recruiting
    • Dongkang Hospital
    • Contact: Byung jun Kim, MD
    • Principal Investigator: Byung jun Kim, MD
  • Yangsan, South Korea
    • Not yet recruiting
    • Pusan National University Yangsan Hospital
    • Principal Investigator: Kook Jin Chun, MD
    • Contact: Kook Jin Chun, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional Arm; The intended regimen is 12 months of DAPT with aspirin plus clopidogrel for CCS or aspirin plus a potent P2Y12 inhibitor (ticagrelor or prasugrel) for ACS. For patients with CCS, a minimum DAPT duration of 6 months is permitted at the treating physician's discretion.	Drug: aspirin; DAPT strategy; Other Names: ticagrelor; clopidogrel; prasugrel
Experimental: Tailored Arm; Patients with CCS receive 1 month of DAPT with aspirin plus clopidogrel, followed by 11 months of clopidogrel monotherapy. Patients with ACS receive 3 months of DAPT with aspirin plus a potent P2Y12 inhibitor (ticagrelor or prasugrel), followed by 9 months of potent P2Y12 inhibitor monotherapy.	Drug: aspirin; DAPT strategy; Other Names: ticagrelor; clopidogrel; prasugrel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite ischemic endpoint	Ischemic composite adverse event of all-cause death, myocardial infarction (MI), ischemia-driven target vessel revascularization (TVR), definite/probable stent thrombosis (ST)	12 month
Net adverse clinical events (NACE)	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]	12 month
Clinically relevant bleeding	Clinically relevant bleeding [Bleeding Academic Research Consortium (BARC) 2, 3, or 5]	12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular death	Sudden cardiac death; death due to acute myocardial infarction (MI), heart failure, cardiogenic shock, stroke, other cardiovascular causes, or fatal bleeding	12 month
Stroke	An acute focal neurologic deficit of presumed vascular origin lasting ≥ 24 h or resulting in death and classified as ischemic or hemorrhagic	12 month
Individual BARC bleeding categories	Type 0 (No bleeding); Type 1 (Minor, Non-Actionable Bleeding); Type 2 (Actionable Bleeding); Type 3 (Major Bleeding); Type 4 (CABG-Related Bleeding); Type 5 (Fatal Bleeding)	12 month
Stent strut coverage in the OCT substudy	% difference of strut coverage on FU OCT between optimal vs. suboptimal DES implantation group	1 or 3 month
Individual components of the composite ischemic endpoint	Individual components of the composite ischemic endpoints including 1) all-cause death; 2) myocardial infarction (MI); 3) ischemia-driven target-vessel revascularization (TVR); and 4) definite or probable stent thrombosis (ST)	12 month

Collaborators and Investigators

• Sponsor: Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2032

Study Registration Dates

• First Submitted: June 7, 2022
• First Submitted That Met QC Criteria: June 12, 2022
• First Posted (Actual): June 14, 2022

Study Record Updates

• Last Update Posted (Actual): September 17, 2026
• Last Update Submitted That Met QC Criteria: September 15, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Nucleic Acids, Nucleotides, and Nucleosides; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Purines; Phenols; Benzene Derivatives; Nucleosides; Ribonucleosides; Thiophenes; Salicylates; Hydroxybenzoates; Adenosine; Purine Nucleosides; Piperazines; Ticlopidine; Thienopyridines; Ticagrelor; Clopidogrel; Prasugrel Hydrochloride; Aspirin
• Other Study ID Numbers: 2022-0568

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No