Personalized anti-platelet therapy for high-risk patients after stent placement
A Randomized Comparison of TAILOReD Anti-Platelet Therapy According to Platelet Reactivity Versus Uniform Clopidogrel Monotherapy Beyond 12 Months After Drug-eluting Stent Implantation in High-risk Patients: TAILOR-DAPT
This study is testing if a personalized anti-platelet treatment can help high-risk patients who have had a stent placed feel better than just taking standard medication alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3434 (estimated) |
| Ages | 19 Years to 80 Years |
| Sex | All |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05936606 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a tailored anti-platelet therapy strategy for high-risk patients who have undergone drug-eluting stent (DES) placement. Participants will be randomly assigned to either continue standard clopidogrel monotherapy or receive personalized treatment based on their platelet reactivity. The intervention aims to optimize antiplatelet therapy beyond 12 months post-stenting, particularly for those with high platelet reactivity. The study will monitor outcomes over a period of up to 24 months.
Who should consider this trial
Good fit: Ideal candidates are patients over 50 years old who have undergone DES implantation and exhibit high-risk characteristics for ischemic events.
Not a fit: Patients over 80 years old or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of ischemic events and bleeding complications in high-risk patients after stent placement.
How similar studies have performed: Other studies have shown promise in personalized antiplatelet therapy, but this specific approach in high-risk DES patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- Severance Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Byeong-Keuk Kim — Severance Cardiovascular Hospital
- Study coordinator: Byeong-Keuk Kim
- Email: kimbk@yuhs.ac
- Phone: 02-2228-8465
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.