Comparing tailored and conventional antiplatelet strategies after optimized stent implantation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the safety and efficacy of a tailored antiplatelet therapy approach, which involves a shorter duration of dual antiplatelet therapy (DAPT) followed by a P2Y12 inhibitor alone, in patients with coronary artery disease who have undergone optimized drug-eluting stent (DES) implantation guided by intravascular imaging techniques such as IVUS or OCT. The study is designed as a prospective, open-label, multi-center, dual-arm, randomized trial involving nearly 4,000 subjects. Participants will be randomly assigned to either the tailored strategy or the conventional DAPT strategy and will be followed clinically for 12 months to assess outcomes related to bleeding and ischemic events.

Why it matters

Who can join: the full rules

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 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.)
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/μl)
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.

Where it's running

• Bucheon Sejong Hospital
  Bucheon-si, South Korea Recruiting
• Dong-A University Hospital
  Busan, South Korea 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

Study contacts

• Study coordinator: Ji Sue Hong, RN
• Email: sue5165@naver.com
• Phone: 82 2-2045-3798

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.