Comparing tailored and conventional antiplatelet strategies after optimized stent implantation
Tailored Versus Coventional AntiPlaTelet Strategy Intended After OPTIMIZEd Drug
This study is testing if a shorter, personalized approach to blood-thinning medication after heart stent placement is safer and more effective than the standard longer treatment for people with coronary artery disease.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 3944 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Asan Medical Center Academic / other |
| Locations | 25 sites (Bucheon-si and 24 other locations) |
| Trial ID | NCT05418556 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are men and women aged 19 and older with significant coronary artery lesions suitable for drug-eluting stent implantation.
Not a fit: Patients with contraindications to antiplatelet therapy or those not suitable for PCI may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a safer antiplatelet strategy that minimizes bleeding risks for patients undergoing stent implantation.
How similar studies have performed: Previous studies have shown promising results with tailored antiplatelet strategies, suggesting potential benefits, although this specific approach is being evaluated in a novel context.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bucheon-si and 24 other locations
- Bucheon Sejong Hospital — Bucheon-si, South Korea (Recruiting)
- Dong-A University Hospital — Busan, South Korea (Recruiting)
- Inje University Busan Paik Hospital — Busan, South Korea (Not_yet_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)
- Daegu Catholic Univ Medical Center — Daegu, South Korea (Not_yet_recruiting)
- Keimyung University Dongsan Medical Center — Daegu, South Korea (Recruiting)
- Kyungpook National University Hospital — Daegu, South Korea (Not_yet_recruiting)
- Veterans Hospital — Daegu, South Korea (Not_yet_recruiting)
- Gangneung Asan Hospital — Gangneung, South Korea (Recruiting)
- Jeonbuk National University Hospital — Jeonju, South Korea (Recruiting)
- Gyeongsang National University Hospital — Jinju, South Korea (Recruiting)
- Chungnam National University Sejong Hospital — Jungnam, South Korea (Recruiting)
- Dankook University Hospital — Jungnam, South Korea (Recruiting)
- Asan Medical Center — Seoul, South Korea (Recruiting)
- Kangbuk Samsung Hospital — Seoul, South Korea (Recruiting)
- Korea University Anam Hospital — Seoul, South Korea (Recruiting)
- The Catholic University of Korea, Eunpyeong St. Mary's Hospital — Seoul, South Korea (Not_yet_recruiting)
- Veterans Hospital Service Medical Center — Seoul, South Korea (Recruiting)
- Ajou University Hospital — Suwon, South Korea (Recruiting)
- The Catholic University of Korea, ST. Vincent's Hospital — Suwon, South Korea (Completed)
- Ulsan University Hospital — Ulsan, South Korea (Recruiting)
- Pusan National University Yangsan Hospital — Yangsan, South Korea (Not_yet_recruiting)
Study contacts
- Study coordinator: Ji Sue Hong, RN
- Email: sue5165@naver.com
- Phone: 82 2-2045-3798
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.