Clinical trial NCT05418556: Tailored Versus Coventional AntiPlaTelet Strategy Intended After OPTIMIZEd Drug Eluting Stent
Official title: Tailored Versus Coventional AntiPlaTelet Strategy Intended After OPTIMIZEd Drug
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Coronary Artery Disease
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2022-06-14
Enrollment: 3944
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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, 6, and 12 months
Primary purpose: TREATMENT

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)

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 1) clinically relevant bleeding [Bleeding Academic Research Consortium (BARC) 2, 3, or 5]
timeFrame: 12 month
measure: 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]
timeFrame: 12 month
measure: 3) ischemic composite adverse event of all-cause death, MI, ischemia-driven target vessel revascularization (TVR), definite/probable stent thrombosis (ST)
timeFrame: 12 month
Secondary outcomes:
measure: 1) Major or minor bleeding according to definitions from TIMI and International Society of Thrombosis or Hemostasis (ISTH)
timeFrame: 12 month
measure: 2) % difference of strut coverage on FU OCT between optimal vs. suboptimal DES implantation group
timeFrame: 1 or 3 month
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Bucheon Sejong Hospital
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Changwon
country: Korea, Republic of
facility: Gyeongsang National University Changwon Hospital
city: Chuncheon
country: Korea, Republic of
facility: Kangwon National University Hospital
city: Chungju
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Chungnam
country: Korea, Republic of
facility: Chungnam National University Sejong Hospital
city: Chungnam
country: Korea, Republic of
facility: Dankook University Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic Univ Medical Center
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daegu
country: Korea, Republic of
facility: Veterans Hospital
city: Gangneung
country: Korea, Republic of
facility: Gangneung Asan Hospital
city: Jeonju
country: Korea, Republic of
facility: Jeonbuk National University Hospital
city: Jinju
country: Korea, Republic of
facility: Gyeongsang National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Eunpyeong St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Veterans Hospital Service Medical Center
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Suwon
country: Korea, Republic of
facility: The Catholic University of Korea, ST. Vincent's Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
Study officials:
References: