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: Seung-Whan Lee, MD; Phone Number: 82 2-3010-3170; Email: seungwlee@amc.seoul.kr

Study Locations

• Korea, Republic of
  • Bucheon, Korea, Republic of
    • Recruiting
    • Bucheon Sejong Hospital
    • Contact: Ha Wook Park, MD
    • Principal Investigator: Ha Wook Park, MD
  • Busan, Korea, Republic of
    • Recruiting
    • Dong-A University Hospital
    • Contact: Yong Rak Cho, MD
    • Principal Investigator: Yong Rak Cho, MD
  • Busan, Korea, Republic of
    • Recruiting
    • Kosin University Gospel Hospital
    • Principal Investigator: Jeong Ho Heo, MD
    • Contact: Jeong Ho Heo, MD
  • Busan, Korea, Republic of
    • Not yet recruiting
    • Inje University Busan Paik Hospital
    • Contact: Tae Hyun Yang, MD
    • Principal Investigator: Tae Hyun Yang, MD
  • Changwon, Korea, Republic of
    • Not yet recruiting
    • Gyeongsang National University Changwon Hospital
    • Principal Investigator: Jae Seok Bae, MD
    • Contact: Jae Seok Bae, MD
  • Chuncheon, Korea, Republic of
    • Recruiting
    • KangWon National University Hospital
    • Contact: Bong Ki Lee, MD
    • Principal Investigator: Bong Ki Lee, MD
  • Chungju, Korea, Republic of
    • Recruiting
    • Chungbuk National University Hospital
    • Contact: Sang Min Kim, MD
    • Principal Investigator: Sang Min Kim, MD
  • Chungnam, Korea, Republic of
    • Recruiting
    • Chungnam National University Sejong Hospital
    • Contact: Jae Hwan Lee, MD
    • Principal Investigator: Jae Hwan Lee, MD
  • Chungnam, Korea, Republic of
    • Not yet recruiting
    • Dankook University Hospital
    • Contact: tae soo kang, MD
    • Sub-Investigator: tae soo kang, MD
  • Daegu, Korea, Republic of
    • Not yet recruiting
    • Keimyung University Dongsan Medical Center
    • Contact: Seung Ho Hur, MD
    • Principal Investigator: Seung Ho Hur, MD
  • Daegu, Korea, Republic of
    • Not yet recruiting
    • Daegu Catholic Univ Medical Center
    • Contact: Jin Bae Lee, MD
    • Principal Investigator: Jin Bae Lee, MD
  • Daegu, Korea, Republic of
    • Not yet recruiting
    • Veterans Hospital
    • Contact: Sang Wook Kang, MD
    • Principal Investigator: Sang Wook Kang, MD
  • Gangneung, Korea, Republic of
    • Not yet recruiting
    • Gangneung Asan Hospital
    • Contact: Han Bit Park, MD
    • Principal Investigator: Han Bit Park, MD
  • Jeonju, Korea, Republic of
    • Not yet recruiting
    • Jeonbuk National University Hospital
    • Contact: Sang Rok Lee, MD
    • Principal Investigator: Sang Rok Lee, MD
  • Jinju, Korea, Republic of
    • Not yet recruiting
    • Gyeongsang National University Hospital
    • Contact: Jin Sin Koh, MD
    • Principal Investigator: Jin Sin Koh, MD
  • Seoul, Korea, Republic of
    • Recruiting
    • Asan Medical Center
    • Contact: Seung-Whan Lee, MD; Email: seungwlee@amc.seoul.kr
    • Principal Investigator: Seung-Whan Lee, MD
    • Sub-Investigator: Tae Oh Kim, MD
    • Sub-Investigator: Pil Hyung Lee, MD
  • Seoul, Korea, Republic of
    • Not yet recruiting
    • Kangbuk Samsung Hospital
    • Contact: Jong Young Lee, MD
    • Principal Investigator: Jong Young Lee, MD
  • Seoul, Korea, Republic of
    • Not yet recruiting
    • Korea University Anam Hospital
    • Contact: Soon Jun Hong, MD
    • Principal Investigator: Soon Jun Hong, MD
  • Seoul, Korea, Republic of
    • 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, Korea, Republic of
    • Recruiting
    • Veterans Hospital Service Medical Center
    • Contact: Chang Hoon Lee, MD
    • Principal Investigator: Chang Hoon Lee, MD
  • Suwon, Korea, Republic of
    • Not yet recruiting
    • Ajou University Hospital
    • Contact: Myeong Ho Yoon, MD
    • Principal Investigator: Myeong Ho Yoon, MD
  • Suwon, Korea, Republic of
    • Not yet recruiting
    • The Catholic university of Korea, St. Vincent's Hospital
    • Contact: Sung Ho Hur, MD
    • Principal Investigator: Sung Ho Hur, MD
  • Ulsan, Korea, Republic of
    • Not yet recruiting
    • Ulsan University Hospital
    • Contact: Gyung Min Park, MD
    • Principal Investigator: Gyung Min Park, MD
  • Yangsan, Korea, Republic of
    • 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): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Aspirin; Ticagrelor; Clopidogrel; Prasugrel Hydrochloride
• 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