Coronary Artery Disease Clinical Trial
Official title:
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
NCT number | NCT05936606 |
Other study ID # | 4-2023-0175 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | August 16, 2023 |
Est. completion date | May 2029 |
Verified date | August 2023 |
Source | Yonsei University |
Contact | Byeong-Keuk Kim |
Phone | 02-2228-8465 |
kimbk[@]yuhs.ac | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 3434 |
Est. completion date | May 2029 |
Est. primary completion date | May 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Severance Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Yonsei University |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Net Clinical Adverse Clinical Events (NACE) for 24 months | A composite of all-cause of death, myocardial infarction (MI), stent thrombosis, stroke, or BARC type 2, 3, or 5 bleeding | upto 2 years after randomization | |
Secondary | All-cause death | upto 2 years after randomization | ||
Secondary | Cardiovascular death | upto 2 years after randomization | ||
Secondary | Myocardial infarction | upto 2 years after randomization | ||
Secondary | Stent thrombosis | upto 2 years after randomization | ||
Secondary | Ischemia-driven target vessel revascularization | upto 2 years after randomization | ||
Secondary | Any revascularization | upto 2 years after randomization | ||
Secondary | Stroke | upto 2 years after randomization | ||
Secondary | Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding | upto 2 years after randomization | ||
Secondary | Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding | upto 2 years after randomization | ||
Secondary | Bleeding Academic Research Consortium (BARC) type 2 bleeding | upto 2 years after randomization | ||
Secondary | Bleeding Academic Research Consortium (BARC) type 3 bleeding | upto 2 years after randomization | ||
Secondary | Bleeding Academic Research Consortium (BARC) type 5 bleeding | upto 2 years after randomization | ||
Secondary | All-cause death, myocardial infarction, or stroke | upto 2 years after randomization | ||
Secondary | Cardiovascular death, myocardial infarction, stent thrombosis, or stroke | upto 2 years after randomization | ||
Secondary | All-cause death, myocardial infarction, stent thrombosis, stroke, or BARC type 3 or 5 bleeding | upto 2 years after randomization |
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