Tailored Versus Coventional AntiPlaTelet Strategy Intended After OPTIMIZEd Drug Eluting Stent (OPTIMIZE-APT)

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)

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, 6, and 12 months

Co-primary Endpoints:

1. Clinically relevant bleeding (BARC 2, 3, or 5) at 12 months post-PCI
2. Ischemic composite adverse events of all-cause death, MI, ischemia-driven TVR, stent thrombosis at 12 months post-PCI
3. Net clinical outcome (NACE) of all-cause death, MI, ischemia-driven TVR, stent thrombosis, BARC 2,3,5 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: Pil Hyung Lee, MD; Phone Number: 82 2-3010-3170; Email: pilmo11@hanmail.net

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
  • 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
    • Not yet recruiting
    • Kyungpook National University Hospital
    • Contact: NAM KYUN KIM, MD
    • Principal Investigator: Nam kyun Kim, MD
  • Daegu, South Korea
    • Recruiting
    • Keimyung University Dongsan Medical Center
    • Contact: Seung Ho Hur, MD
    • Principal Investigator: Seung Ho Hur, MD
  • Daegu, South Korea
    • Not yet recruiting
    • Daegu Catholic Univ Medical Center
    • Contact: Jin Bae Lee, MD
    • Principal Investigator: Jin Bae Lee, MD
  • Daegu, South Korea
    • Not yet recruiting
    • Veterans Hospital
    • Contact: Sang Wook Kang, MD
    • Principal Investigator: Sang Wook Kang, MD
  • Gangneung, South Korea
    • Recruiting
    • GangNeung Asan Hospital
    • Contact: Han Bit Park, MD
    • Principal Investigator: Han Bit Park, MD
  • Jeonju, South Korea
    • Recruiting
    • Jeonbuk National University Hospital
    • Contact: Sang Rok Lee, MD
    • Principal Investigator: Sang Rok Lee, 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: Jae Hwan Lee, MD
    • Principal Investigator: Jae Hwan Lee, MD
  • Jungnam, South Korea
    • Recruiting
    • Dankook University Hospital
    • Contact: tae soo kang, MD
    • Sub-Investigator: tae soo kang, MD
  • Seoul, South Korea
    • Recruiting
    • Asan Medical Center
    • Principal Investigator: Seung-Whan Lee, MD
    • Sub-Investigator: Tae Oh Kim, MD
    • Sub-Investigator: Pil Hyung Lee, MD
    • Contact: Pil Hyung Lee, MD; Email: pilmo11@hanmail.net
  • 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: Jong Young Lee, MD
    • Principal Investigator: Jong Young Lee, MD
  • Seoul, South Korea
    • Not yet 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
    • 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
  • Ulsan, South Korea
    • Recruiting
    • Ulsan University Hospital
    • Contact: Gyung Min Park, MD
    • Principal Investigator: Gyung Min Park, 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/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.

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; After PCI, patients are prescribed aspirin at a daily dose of 100 mg PO plus a P2Y12 inhibitor [clopidogrel or ticagrelor or prasugrel according to the clinical diagnosis] for 12 months after the index PCI.	Drug: aspirin; DAPT strategy; Other Names: ticagrelor; clopidogrel; prasugrel
Experimental: Tailored Arm; 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.	Drug: aspirin; DAPT strategy; Other Names: ticagrelor; clopidogrel; prasugrel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	2) % difference of strut coverage on FU OCT between optimal vs. suboptimal DES implantation group	1 or 3 month

Collaborators and Investigators

• Sponsor: Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2022
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): December 31, 2028

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): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 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