NCT05936606 Tailored Anti-platelet Therapy After DES Implantation in High-risk Patients
| NCT ID | NCT05936606 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yonsei University |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,434 participants |
| Start Date | 2023-08-16 |
| Primary Completion | 2027-05 |
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.
This trial targets 3,434 participants in total. It began in 2023-08-16 with a primary completion date of 2027-05.
⚠ 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
Clopidogrel monotherapy has been found effective in reducing ischaemic cardiovascular and haemorrhagic complications in patients with drug-eluting stent (DES) placement. However, concerns remain about the safety of long-term clopidogrel monotherapy in high-risk patients with HPR (high platelet reactivity) who do not respond adequately to clopidogrel. This study aims to evaluate the effectiveness of a patient-tailored antiplatelet therapy strategy that considers platelet aggregation in high-risk patients with DES placement beyond 12 months after stenting.
Eligibility Criteria
Inclusion Criteria: 1. Patients \> 18 years old 2. Patients who previously underwent percutaneous coronary intervention with drug-eluting stent implantation 12 months (± 3 months) ago. 3. At least one high risk characteristics of ischemic events High risk patients 1. Acute coronary syndrome 2. Previous history of cerebrovascular accidents 3. Previous history of peripheral artery intervention 4. Heart failure 5. Diabetes mellitus requiring medication 6. Chronic kidney disease (regardless of requirement of renal replacement therapy) High risk lesions 1. Left main disease 2. Multivessel disease, 2- or 3- vessels 3. Bifurcation lesions requiring 2 or more stents 4. Chronic total occlusion 5. In-stent restenosis 6. Graft lesions 7. Diffuse long lesion requiring stent(s) with total stent length ≥28 mm 8. Lesion at small sized vessel requiring stent(s) with stent diameter ≤2.5 mm 9. Calcified lesions requiring atherectomy Exclusion Criteria: 1. Patients \> 80 years old 2. Pregnant women or women with potential childbearing 3. Life expectancy \< 1 year 4. Refusal or inability to understand of informed consent 5. Patients eligible to long-term anticoagulation therapy 6. Patients with major bleeding events in previous 3 months before randomization
Contact & Investigator
Byeong-Keuk Kim
PRINCIPAL INVESTIGATOR
Severance Cardiovascular Hospital
Frequently Asked Questions
Who can join the NCT05936606 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 80 Years, 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.
Is NCT05936606 currently recruiting?
Yes, NCT05936606 is actively recruiting participants. Contact the research team at kimbk@yuhs.ac for enrollment information.
Where is the NCT05936606 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT05936606 clinical trial?
NCT05936606 is sponsored by Yonsei University. The principal investigator is Byeong-Keuk Kim at Severance Cardiovascular Hospital. The trial plans to enroll 3,434 participants.