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RecruitingNCT05418556OPTIMIZE-APTUpdated Sep 17, 2026

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

A Phase 4 interventional study of aspirin in Coronary Artery Disease, sponsored by Asan Medical Center. Recruiting at 33 sites in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Asan Medical Center · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2022; still recruiting 4 years later.
Phase
Phase 4
Study type
Interventional
Enrollment
3,944
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

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)

Read the 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.

02

Conditions studied

  • Coronary Artery Disease
03

In context

Coronary Artery Disease

4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.

This study's planned enrollment of 3,944 is above the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Asan Medical Center is the lead sponsor of 578 studies on the registry; 73 are open to participants now.

Browse Asan Medical Center studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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. or 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 ( count \<80,000/μl)
  5. Any history of hemorrhagic stroke or intracranial hemorrhage / 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 abnormality identified at the screening visit, physical examination, laboratory tests, or which, in the judgment of the Investigator, would preclude safe completion of the study.
  11. History of liver cirrhosis ( B or C) or biliary tract obstruction
  12. \< 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, with a high risk for bleeding)
  16. Unwillingness or inability to comply with the procedures described in this protocol.
Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
3,944 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • Drugaspirin

    DAPT strategy

    Also known as: clopidogrel, prasugrel, ticagrelor

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 12 month

  2. 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 \[BARC 2, 3, or 5\]

    Time frame: 12 month

  3. Clinically relevant bleeding

    Clinically relevant bleeding \[Bleeding Academic Research Consortium (BARC) 2, 3, or 5\]

    Time frame: 12 month

Secondary outcomes

  1. 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)

    Time frame: 12 month

  2. Cardiovascular death

    Sudden cardiac death; death due to acute myocardial infarction (MI), heart failure, cardiogenic shock, stroke, other cardiovascular causes, or fatal bleeding

    Time frame: 12 month

  3. Stroke

    An acute focal neurologic deficit of presumed vascular origin lasting ≥ 24 h or resulting in death and classified as ischemic or hemorrhagic

    Time frame: 12 month

  4. 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)

    Time frame: 12 month

  5. Stent strut coverage in the OCT substudy

    % difference of strut coverage on FU OCT between optimal vs. suboptimal DES implantation group

    Time frame: 1 or 3 month

07

Study locations

24 of 33 sites recruiting
  • Bucheon Sejong Hospital
    Bucheon-si, South Korea
    Recruiting
    • Ha Wook Park, MD · Contact
    • Ha Wook Park, MD · Principal investigator
  • Dong-A University Hospital
    Busan, South Korea
    Recruiting
    • Yong Rak Cho, MD · Contact
    • Yong Rak Cho, MD · Principal investigator
  • Inje University Busan Paik Hospital
    Busan, South Korea
    Not yet recruiting
    • Tae Hyun Yang, MD · Contact
    • Tae Hyun Yang, MD · Principal investigator
  • Inje University Haeundae Paik Hospital
    Busan, South Korea
    Not yet recruiting
    • Dongk-kie Kim, MD · Contact
    • Dongk-kie Kim, MD · Principal investigator
  • Kosin University Gospel Hospital
    Busan, South Korea
    Recruiting
    • Jeong Ho Heo, MD · Contact
    • Jeong Ho Heo, MD · Principal investigator
  • Gyeongsang National University Changwon Hospital
    Changwon, South Korea
    Recruiting
    • Jae Seok Bae, MD · Contact
    • Jae Seok Bae, MD · Principal investigator
  • Kangwon National University Hospital
    Chuncheon, South Korea
    Recruiting
    • Bong Ki Lee, MD · Contact
    • Bong Ki Lee, MD · Principal investigator
  • Chungbuk National University Hospital
    Chungju, South Korea
    Recruiting
    • Sang Min Kim, MD · Contact
    • Sang Min Kim, MD · Principal investigator
  • Daegu Catholic Univ Medical Center
    Daegu, South Korea
    Not yet recruiting
    • Jin Bae Lee, MD · Contact
    • Jin Bae Lee, MD · Principal investigator
  • Keimyung University Dongsan Medical Center
    Daegu, South Korea
    Recruiting
    • Hyuck jun yoon, MD · Contact
    • Hyuck jun yoon, MD · Principal investigator
  • Kyungpook National University Hospital
    Daegu, South Korea
    Recruiting
    • NAM KYUN KIM, MD · Contact
    • Nam kyun Kim, MD · Principal investigator
  • Veterans Hospital
    Daegu, South Korea
    Recruiting
    • Sang Wook Kang, MD · Contact
    • Sang Wook Kang, MD · Principal investigator
  • The Catholic University of Korea, Daejeon ST. Mary's Hospital
    Daejeon, South Korea
    Recruiting
    • Kyusup Lee, MD · Contact
    • Kyusup Lee, MD · Principal investigator
  • Gangneung Asan Hospital
    Gangneung, South Korea
    Recruiting
    • Han Bit Park, MD · Contact
    • Han Bit Park, MD · Principal investigator
  • Hallym Univ. Medical Center.
    Hwaseong-si, South Korea
    Not yet recruiting
    • Jeen Hwa Lee, MD · Contact
    • Jeen Hwa Lee, MD · Principal investigator
  • dongguk University Medical Center
    Ilsan, South Korea
    Not yet recruiting
    • Jae sik Jang, MD · Contact
    • Jae sik Jang, MD · Principal investigator
  • Jeju National University Hospital
    Jeju City, South Korea
    Recruiting
    • Joon Hyouk Choi, MD · Contact
    • Joon Hyouk Choi, MD · Principal investigator
  • Jeonbuk National University Hospital
    Jeonju, South Korea
    Recruiting
    • Yisik Kim, MD · Contact
    • Yisik Kim, MD · Principal investigator
  • Gyeongsang National University Hospital
    Jinju, South Korea
    Recruiting
    • Jin Sin Koh, MD · Contact
    • Jin Sin Koh, MD · Principal investigator
  • Chungnam National University Hospital
    Jungnam, South Korea
    Recruiting
    • Jae Hwan Lee, MD · Contact
    • Jae Hwan Lee, MD · Principal investigator
  • Chungnam National University Sejong Hospital
    Jungnam, South Korea
    Recruiting
    • Won mook Hwang, MD · Contact
    • Won mook Hwang, MD · Principal investigator
  • Dankook University Hospital
    Jungnam, South Korea
    Recruiting
    • tae soo kang, MD · Contact
    • tae soo kang, MD · Principal investigator
  • Asan Medical Center
    Seoul, South Korea
    Recruiting
    • Seung-Whan Lee, MD · Contactseungwlee@amc.seoul.kr
    • Seung-Whan Lee, MD · Principal investigator
    • Tae Oh Kim, MD · Sub investigator
  • Kangbuk Samsung Hospital
    Seoul, South Korea
    Recruiting
    • seung jae Lee, MD · Contact
    • seung jae Lee, MD · Principal investigator
  • Korea University Anam Hospital
    Seoul, South Korea
    Recruiting
    • Soon Jun Hong, MD · Contact
    • Soon Jun Hong, MD · Principal investigator
  • The Catholic University of Korea, Eunpyeong St. Mary's Hospital
    Seoul, South Korea
    Recruiting
    • Pum Joon Kim, MD · Contact
    • Pum Joon Kim, MD · Principal investigator
  • Veterans Hospital Service Medical Center
    Seoul, South Korea
    Recruiting
    • Chang Hoon Lee, MD · Contact
    • Chang Hoon Lee, MD · Principal investigator
  • Ajou University Hospital
    Suwon, South Korea
    Recruiting
    • Myeong Ho Yoon, MD · Contact
    • Myeong Ho Yoon, MD · Principal investigator
  • The Catholic University of Korea, ST. Vincent's Hospital
    Suwon, South Korea
    Completed

    Not enrolling at this site — choose another above.

  • The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
    Uijeongbu-si, South Korea
    Not yet recruiting
    • Chan Joon Kim, MD · Contact
    • Chan Joon Kim, MD · Principal investigator
  • Dongkang Hospital
    Ulsan, South Korea
    Not yet recruiting
    • Byung jun Kim, MD · Contact
    • Byung jun Kim, MD · Principal investigator
  • Ulsan University Hospital
    Ulsan, South Korea
    Recruiting
    • Gyung Min Park, MD · Contact
    • Gyung Min Park, MD · Principal investigator
  • Pusan National University Yangsan Hospital
    Yangsan, South Korea
    Not yet recruiting
    • Kook Jin Chun, MD · Contact
    • Kook Jin Chun, MD · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2022 (actual). Primary completion is estimated for Dec 2027, 62 months after the start.

Of 180 non-industry phase 4 interventional studies under Coronary Artery Disease, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 59. This study's planned 62 months is above that.

Counting every sponsor, half of 193 studies reached it within 35 months; a quarter within 19 and three quarters within 58.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 7, 2022
First posted
Jun 14, 2022
StartActual
Oct 21, 2022
Primary completionEst.
Dec 31, 2027
CompletionEst.
Dec 31, 2032
Last update
Sep 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05418556
Lead sponsor
Asan Medical Center
Responsible party
Seung-Whan Lee, M.D., Ph.D. (Part of Cardiology, Principal Investigator, associate professor, Asan Medical Center) — Principal investigator
First posted
Jun 14, 2022
Start date
Oct 21, 2022
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2032 (estimated)
Last update
Sep 17, 2026

Study contacts

Ji Sue Hong, RN
Contact
sue5165@naver.com
82 2-2045-3798
Seung-Whan Lee, MD
Contact
seungwlee@amc.seoul.kr
82 2-3010-3170

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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