NCT05418556 Tailored Versus Coventional AntiPlaTelet Strategy Intended After OPTIMIZEd Drug Eluting Stent
| NCT ID | NCT05418556 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Asan Medical Center |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,944 participants |
| Start Date | 2022-10-21 |
| Primary Completion | 2027-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 3,944 participants in total. It began in 2022-10-21 with a primary completion date of 2027-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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)
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05418556 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05418556 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05418556 currently recruiting?
Yes, NCT05418556 is actively recruiting participants. Contact the research team at sue5165@naver.com for enrollment information.
Where is the NCT05418556 trial being conducted?
This trial is being conducted at Bucheon-si, South Korea, Busan, South Korea, Busan, South Korea, Busan, South Korea and 11 additional locations.
Who is sponsoring the NCT05418556 clinical trial?
NCT05418556 is sponsored by Asan Medical Center. The trial plans to enroll 3,944 participants.