Tailored Versus Coventional AntiPlaTelet Strategy Intended After OPTIMIZEd Drug Eluting Stent

Last updated: August 26, 2024
Sponsor: Asan Medical Center
Overall Status: Active - Recruiting

Phase

4

Condition

Cardiac Disease

Thrombosis

Hypercholesterolemia

Treatment

aspirin

Clinical Study ID

NCT05418556
2022-0568
  • Ages > 19
  • All Genders

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)

Eligibility Criteria

Inclusion

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%

  1. The patient or guardian agrees to the study protocol and the schedule of clinicalfollow-up, and provides informed, written consent, as approved by the appropriateInstitutional Review Board/Ethical Committee of the respective clinical site

Exclusion

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 targetlesion.

  • Heavy calcification proximal to or within the target lesion.

  1. In-stent restenosis

  2. Hypersensitivity or contraindication to device material and its degradants andcobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers thatcannot be adequately pre-medicated.

  3. Persistent thrombocytopenia (platelet count <80,000/l)

  4. Any history of hemorrhagic stroke or intracranial hemorrhage / TIA or ischemicstroke within the past 6 months

  5. A known intolerance or hypersensitivity to a study drug (aspirin, clopidogrel orticagrelor) or heparin

  6. Patients requiring long-term oral anticoagulants or cilostazol

  7. Any surgery requiring general anesthesia or discontinuation of aspirin and/or an ADPantagonist is planned within 12 months after the procedure.

  8. A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) inthe past 3 years or current treatment for the active cancer.

  9. Any clinically significant abnormality identified at the screening visit, physicalexamination, laboratory tests, or electrocardiogram which, in the judgment of theInvestigator, would preclude safe completion of the study.

  10. History of liver cirrhosis (Child-Pugh B or C) or biliary tract obstruction

  11. Life expectancy < 1 years for any non-cardiac or cardiac causes

  12. Cardiogenic shock at the index admission

  13. Patient's pregnant or breast-feeding

  14. Active bleeding or extreme-risk for major bleeding (e.g. active peptic ulcerdisease, gastrointestinal pathology with a high risk for bleeding, malignancies witha high risk for bleeding)

  15. Unwillingness or inability to comply with the procedures described in this protocol.

Study Design

Total Participants: 3944
Treatment Group(s): 1
Primary Treatment: aspirin
Phase: 4
Study Start date:
October 21, 2022
Estimated Completion Date:
December 31, 2028

Study 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.

Connect with a study center

  • Bucheon Sejong Hospital

    Bucheon,
    Korea, Republic of

    Active - Recruiting

  • Dong-A University Hospital

    Busan,
    Korea, Republic of

    Active - Recruiting

  • Inje University Busan Paik Hospital

    Busan,
    Korea, Republic of

    Site Not Available

  • Kosin University Gospel Hospital

    Busan,
    Korea, Republic of

    Active - Recruiting

  • Gyeongsang National University Changwon Hospital

    Changwon,
    Korea, Republic of

    Active - Recruiting

  • Kangwon National University Hospital

    Chuncheon,
    Korea, Republic of

    Active - Recruiting

  • Chungbuk National University Hospital

    Chungju,
    Korea, Republic of

    Active - Recruiting

  • Chungnam National University Sejong Hospital

    Chungnam,
    Korea, Republic of

    Active - Recruiting

  • Dankook University Hospital

    Chungnam,
    Korea, Republic of

    Active - Recruiting

  • Daegu Catholic Univ Medical Center

    Daegu,
    Korea, Republic of

    Site Not Available

  • Keimyung University Dongsan Medical Center

    Daegu,
    Korea, Republic of

    Active - Recruiting

  • Kyungpook National University Hospital

    Daegu,
    Korea, Republic of

    Site Not Available

  • Veterans Hospital

    Daegu,
    Korea, Republic of

    Site Not Available

  • Gangneung Asan Hospital

    Gangneung,
    Korea, Republic of

    Active - Recruiting

  • Jeonbuk National University Hospital

    Jeonju,
    Korea, Republic of

    Active - Recruiting

  • Gyeongsang National University Hospital

    Jinju,
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Kangbuk Samsung Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Korea University Anam Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

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

    Seoul,
    Korea, Republic of

    Site Not Available

  • Veterans Hospital Service Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Ajou University Hospital

    Suwon,
    Korea, Republic of

    Active - Recruiting

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

    Suwon,
    Korea, Republic of

    Completed

  • Ulsan University Hospital

    Ulsan,
    Korea, Republic of

    Active - Recruiting

  • Pusan National University Yangsan Hospital

    Yangsan,
    Korea, Republic of

    Site Not Available

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