Tailored Antiplatelet Therapy for High-Risk Patients At 12 Months after Drug-Eluting Stent implantation

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 Trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0008489

Enrollment

3434

Registered

2023-06-02

Start date

2023-08-16

Completion date

Unknown

Last updated

2024-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : This study will randomly assign eligible participants who underwent drug-eluting stent placement and have maintained the standard antiplatelet therapy for 12 months to either a control group or

for HPR patients (PRU=208), dual antiplatelet therapy will be prescribed based on clinical diagnosis at the time of stent implantation and individual patients' ischemic/bleeding risk profiles. Patient

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients > 18 years old 2. atients 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

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

Design outcomes

Primary

Measure	Time frame
Net clinical adverse event [NACE]	—

Secondary

Measure	Time frame
All-cause death ;Cardiovascular death;Myocardial infarction;Stent thrombosis;Ischemia-driven target vessel revascularization;Any revascularization;Stroke;BARC type 2, 3, or 5 bleeding;BARC type 3, or 5 bleeding;BARC type 2 bleeding;BARC type 3 bleeding;BARC type 5 bleeding;All-cause death, myocardial infarction, or stroke;Cardiovascular death, myocardial infarction, stent thrombosis, or stroke;All-cause death, myocardial infarction, stent thrombosis, stroke, or BARC type 3 or 5 bleeding	—

Measure

Time frame

All-cause death ;Cardiovascular death;Myocardial infarction;Stent thrombosis;Ischemia-driven target vessel revascularization;Any revascularization;Stroke;BARC type 2, 3, or 5 bleeding;BARC type 3, or 5 bleeding;BARC type 2 bleeding;BARC type 3 bleeding;BARC type 5 bleeding;All-cause death, myocardial infarction, or stroke;Cardiovascular death, myocardial infarction, stent thrombosis, or stroke;All-cause death, myocardial infarction, stent thrombosis, stroke, or BARC type 3 or 5 bleeding

—

Countries

Korea, Republic of

Contacts

Public ContactByeong-Keuk Kim

Yonsei University Health System, Severance Hospital

kimbk@yuhs.ac+82-2-2228-8465

Outcome results