Tailored Versus Coventional AntiPlaTelet Strategy Intended After OPTIMIZEd Drug Eluting Stent
OPTIMIZE-APT
1 other identifier
interventional
3,944
1 country
25
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 coronary-artery-disease
Started Oct 2022
Longer than P75 for phase_4 coronary-artery-disease
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2022
CompletedFirst Posted
Study publicly available on registry
June 14, 2022
CompletedStudy Start
First participant enrolled
October 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
March 30, 2026
March 1, 2026
4.9 years
June 7, 2022
March 26, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (2)
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
1 or 3 month
Study Arms (2)
Conventional Arm
ACTIVE COMPARATORAfter 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.
Tailored Arm
EXPERIMENTALThe 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.
Interventions
DAPT strategy
Eligibility Criteria
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/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%
- 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/l)
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Bucheon Sejong Hospital
Bucheon-si, South Korea
Dong-A University Hospital
Busan, South Korea
Inje University Busan Paik Hospital
Busan, South Korea
Kosin University Gospel Hospital
Busan, South Korea
Gyeongsang National University Changwon Hospital
Changwon, South Korea
Kangwon National University Hospital
Chuncheon, South Korea
Chungbuk National University Hospital
Chungju, South Korea
Daegu Catholic Univ Medical Center
Daegu, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
Kyungpook National University Hospital
Daegu, South Korea
Veterans Hospital
Daegu, South Korea
Gangneung Asan Hospital
Gangneung, South Korea
Jeonbuk National University Hospital
Jeonju, South Korea
Gyeongsang National University Hospital
Jinju, South Korea
Chungnam National University Sejong Hospital
Jungnam, South Korea
Dankook University Hospital
Jungnam, South Korea
Asan Medical Center
Seoul, South Korea
Kangbuk Samsung Hospital
Seoul, South Korea
Korea University Anam Hospital
Seoul, South Korea
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, South Korea
Veterans Hospital Service Medical Center
Seoul, South Korea
Ajou University Hospital
Suwon, South Korea
The Catholic University of Korea, ST. Vincent's Hospital
Suwon, South Korea
Ulsan University Hospital
Ulsan, South Korea
Pusan National University Yangsan Hospital
Yangsan, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
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
Study Record Dates
First Submitted
June 7, 2022
First Posted
June 14, 2022
Study Start
October 21, 2022
Primary Completion (Estimated)
August 30, 2027
Study Completion (Estimated)
December 31, 2028
Last Updated
March 30, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share