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

NCT05418556 | Recruiting Phase 4 DMC

• 1 other identifier: 2022-0568
• Study Type: interventional
• Target: 3,944
• Locations: 1 country
• Sites: 33

Brief 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)

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Individual components of the composite ischemic endpoint

  12 month

• Cardiovascular death

  12 month

• Stroke

  12 month

• Individual BARC bleeding categories

  12 month

• Stent strut coverage in the OCT substudy

  1 or 3 month

Study Arms (2)

Conventional Arm

ACTIVE COMPARATOR

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

Tailored Arm

EXPERIMENTAL

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

aspirin DRUG

DAPT strategy

Also known as: clopidogrel, prasugrel, ticagrelor

Conventional Arm; Tailored Arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (33)

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

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Aspirin; Clopidogrel; Prasugrel Hydrochloride; Ticagrelor

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Piperazines; Adenosine; Purine Nucleosides; Purines; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Part of Cardiology, Principal Investigator, associate professor

Model Details: * 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

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 14, 2022
• Study Start: October 21, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2032
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (33)