AzTrials
AzTrials

Coronary Artery DiseasePhase 4OPTIMIZE-APTNCT05418556

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

A Phase 4 study testing aspirin in people with Coronary Artery Disease, run by Asan Medical Center at 33 sites in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
aspirin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,944 participants
Where
33 sitesSouth Korea
Study dates
21 Oct 2022to 31 Dec 2032
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 15Show fewer
  • 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.)
  • 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

Who cannot join

  • 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.
Show all 19Show fewer
  • Persistent thrombocytopenia (platelet count <80,000/μl)
  • 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.

Trial locations and contacts

33 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ji Sue Hong, RN contact

82 2-2045-3798

sue5165@naver.com

Seung-Whan Lee, MD contact

82 2-3010-3170

seungwlee@amc.seoul.kr

33 sites in 1 country

South Korea33 sites, 32 recruiting

  • Bucheon Sejong Hospital

    Bucheon-si

    Ha Wook Park, MD

    Ha Wook Park, MD

    Recruiting

  • Dong-A University Hospital

    Busan

    Yong Rak Cho, MD

    Yong Rak Cho, MD

    Recruiting

  • Inje University Busan Paik Hospital

    Busan

    Tae Hyun Yang, MD

    Tae Hyun Yang, MD

    Not yet recruiting

  • Inje University Haeundae Paik Hospital

    Busan

    Dongk-kie Kim, MD

    Dongk-kie Kim, MD

    Not yet recruiting

  • Kosin University Gospel Hospital

    Busan

    Jeong Ho Heo, MD

    Jeong Ho Heo, MD

    Recruiting

  • Gyeongsang National University Changwon Hospital

    Changwon

    Jae Seok Bae, MD

    Jae Seok Bae, MD

    Recruiting

  • Kangwon National University Hospital

    Chuncheon

    Bong Ki Lee, MD

    Bong Ki Lee, MD

    Recruiting

  • Chungbuk National University Hospital

    Chungju

    Sang Min Kim, MD

    Sang Min Kim, MD

    Recruiting

  • Daegu Catholic Univ Medical Center

    Daegu

    Jin Bae Lee, MD

    Jin Bae Lee, MD

    Not yet recruiting

  • Keimyung University Dongsan Medical Center

    Daegu

    Hyuck jun yoon, MD

    Hyuck jun yoon, MD

    Recruiting

  • Kyungpook National University Hospital

    Daegu

    NAM KYUN KIM, MD

    Nam kyun Kim, MD

    Recruiting

  • Veterans Hospital

    Daegu

    Sang Wook Kang, MD

    Sang Wook Kang, MD

    Recruiting

  • The Catholic University of Korea, Daejeon ST. Mary's Hospital

    Daejeon

    Kyusup Lee, MD

    Kyusup Lee, MD

    Recruiting

  • Gangneung Asan Hospital

    Gangneung

    Han Bit Park, MD

    Han Bit Park, MD

    Recruiting

  • Hallym Univ. Medical Center.

    Hwaseong-si

    Jeen Hwa Lee, MD

    Jeen Hwa Lee, MD

    Not yet recruiting

  • dongguk University Medical Center

    Ilsan

    Jae sik Jang, MD

    Jae sik Jang, MD

    Not yet recruiting

  • Jeju National University Hospital

    Jeju City

    Joon Hyouk Choi, MD

    Joon Hyouk Choi, MD

    Recruiting

  • Jeonbuk National University Hospital

    Jeonju

    Yisik Kim, MD

    Yisik Kim, MD

    Recruiting

  • Gyeongsang National University Hospital

    Jinju

    Jin Sin Koh, MD

    Jin Sin Koh, MD

    Recruiting

  • Chungnam National University Hospital

    Jungnam

    Jae Hwan Lee, MD

    Jae Hwan Lee, MD

    Recruiting

  • Chungnam National University Sejong Hospital

    Jungnam

    Won mook Hwang, MD

    Won mook Hwang, MD

    Recruiting

  • Dankook University Hospital

    Jungnam

    tae soo kang, MD

    tae soo kang, MD

    Recruiting

  • Asan Medical Center

    Seoul

    Seung-Whan Lee, MD, seungwlee@amc.seoul.kr

    Seung-Whan Lee, MD

    Recruiting

  • Kangbuk Samsung Hospital

    Seoul

    seung jae Lee, MD

    seung jae Lee, MD

    Recruiting

  • Korea University Anam Hospital

    Seoul

    Soon Jun Hong, MD

    Soon Jun Hong, MD

    Recruiting

  • The Catholic University of Korea, Eunpyeong St. Mary's Hospital

    Seoul

    Pum Joon Kim, MD

    Pum Joon Kim, MD

    Recruiting

  • Veterans Hospital Service Medical Center

    Seoul

    Chang Hoon Lee, MD

    Chang Hoon Lee, MD

    Recruiting

  • Ajou University Hospital

    Suwon

    Myeong Ho Yoon, MD

    Myeong Ho Yoon, MD

    Recruiting

  • The Catholic University of Korea, ST. Vincent's Hospital

    Suwon

    Completed

  • The Catholic University of Korea, Uijeongbu ST. Mary's Hospital

    Uijeongbu-si

    Chan Joon Kim, MD

    Chan Joon Kim, MD

    Not yet recruiting

  • Dongkang Hospital

    Ulsan

    Byung jun Kim, MD

    Byung jun Kim, MD

    Not yet recruiting

  • Ulsan University Hospital

    Ulsan

    Gyung Min Park, MD

    Gyung Min Park, MD

    Recruiting

  • Pusan National University Yangsan Hospital

    Yangsan

    Kook Jin Chun, MD

    Kook Jin Chun, MD

    Not yet recruiting

Other trials in South Korea

About this study

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.

Being tested
aspirin
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • aspirinDrug

    Also called clopidogrel, prasugrel, ticagrelor

    DAPT strategy

Study groups in NCT05418556
Study groupRoleWhat they receive
Conventional ArmActive comparatorThe 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.
Receives: Drug: aspirin
Tailored ArmExperimentalPatients 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.
Receives: Drug: aspirin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 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]

    Measured: 12 month

  3. Clinically relevant bleeding

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

    Measured: 12 month

Secondary outcomes (5)

  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)

    Measured: 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

    Measured: 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

    Measured: 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)

    Measured: 12 month

  5. Stent strut coverage in the OCT substudy

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

    Measured: 1 or 3 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2022
  2. Study start21 Oct 2022
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
* 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
Masking
None (open label)
Enrolment
3,944 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05418556
Sponsor's protocol ID
2022-0568
Acronym
OPTIMIZE-APT
Status last verified
Sep 2026
First submitted
7 Jun 2022
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing aspirin in people with Coronary Artery Disease, run by Asan Medical Center at 33 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ji Sue Hong, RN (82 2-2045-3798, sue5165@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite ischemic endpoint (time frame: 12 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05418556.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in