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Tailored Anti-platelet Therapy After DES Implantation in High-risk Patients

Primary Purpose

Coronary Artery Disease

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Clopidogrel monotherapy
Tailored anti-platelet therapy
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary artery disease, antiplatelet therapy, platelet reactivity

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients > 18 years old Patients who previously underwent percutaneous coronary intervention with drug-eluting stent implantation 12 months (± 3 months) ago. At least one high risk characteristics of ischemic events High risk patients Acute coronary syndrome Previous history of cerebrovascular accidents Previous history of peripheral artery intervention Heart failure Diabetes mellitus requiring medication Chronic kidney disease (regardless of requirement of renal replacement therapy) High risk lesions Left main disease Multivessel disease, 2- or 3- vessels Bifurcation lesions requiring 2 or more stents Chronic total occlusion In-stent restenosis Graft lesions Diffuse long lesion requiring stent(s) with total stent length ≥28 mm Lesion at small sized vessel requiring stent(s) with stent diameter ≤2.5 mm Calcified lesions requiring atherectomy Exclusion Criteria: Patients > 80 years old Pregnant women or women with potential childbearing Life expectancy < 1 year Refusal or inability to understand of informed consent Patients eligible to long-term anticoagulation therapy Patients with major bleeding events in previous 3 months before randomization

Sites / Locations

  • Severance HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Uniform Therapy

Tailored Therapy

Arm Description

Patients will continue clopidogrel monotherapy for 24 months from randomization, irrespective of their PRU measurement.

Patients in the intervention arm will receive tailored anti-platelet therapy according to PRU and bleeding risk

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

All-cause death
Cardiovascular death
Myocardial infarction
Stent thrombosis
Ischemia-driven target vessel revascularization
Any revascularization
Stroke
Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding
Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding
Bleeding Academic Research Consortium (BARC) type 2 bleeding
Bleeding Academic Research Consortium (BARC) type 3 bleeding
Bleeding Academic Research Consortium (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

Full Information

First Posted
May 22, 2023
Last Updated
August 27, 2023
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT05936606
Brief Title
Tailored Anti-platelet Therapy After DES Implantation in High-risk Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 16, 2023 (Actual)
Primary Completion Date
May 2027 (Anticipated)
Study Completion Date
May 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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 an intervention group. The control group will continue receiving clopidogrel monotherapy for 24 months regardless of their PRU (platelet reactivity unit) values. The intervention group will receive personalized antiplatelet therapy based on their PRU values: for non-HPR patients (PRU<208), clopidogrel monotherapy will be continued; 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. Patients (≥50 years) who presented with acute myocardial infarction at the time of coronary intervention, and have high-risk characteristics (① ≥65 years ② multi-vessel disease ③ diabetes mellitus ④ chronic kidney disease ⑤ recurrent myocardial infarction) will receive ticagrelor 60 mg twice daily with aspirin, whereas the remainder will receive clopidogrel with aspirin. For high-bleeding-risk patients with two or more major bleeding risk factors according to ARC-HBR, the investigator may consider early discontinuation of dual antiplatelet therapy or de-escalation therapy like aspirin monotherapy based on the patient's risk profile. The treatment assignment ratio is 1:1. The study period will be up to 24 months from the time of randomization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary artery disease, antiplatelet therapy, platelet reactivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be assigned to receive either standard clopidogrel monotherapy or tailored antiplatelet therapy at 12 months after DES implantation.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3434 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Uniform Therapy
Arm Type
Active Comparator
Arm Description
Patients will continue clopidogrel monotherapy for 24 months from randomization, irrespective of their PRU measurement.
Arm Title
Tailored Therapy
Arm Type
Experimental
Arm Description
Patients in the intervention arm will receive tailored anti-platelet therapy according to PRU and bleeding risk
Intervention Type
Drug
Intervention Name(s)
Clopidogrel monotherapy
Intervention Description
Patients will receive clopidogrel monotherapy (75 mg qd) for 24 months after randomization, irrespective of PRU value or bleeding risk.
Intervention Type
Drug
Intervention Name(s)
Tailored anti-platelet therapy
Intervention Description
In the tailored therapy arm, non-HPR (PRU<208) patients will continue clopidogrel monotherapy until the end of the study at 24 months from randomization, while HPR (PRU≥208) patients will receive dual anti-platelet therapy according to the clinical diagnosis at the time of drug-eluting stent placement: High-risk patients with prior myocardial infarction will receive ticagrelor 60 mg twice daily wiht aspirin 100 mg daily, while the remainder will receive clopidogrel 75 mg daily with aspirin 100 mg daily. For HBR patietns, early cessation of dual antiplatelet therapy or aspirin monotherapy could be considered at the investigator's discretion.
Primary Outcome Measure Information:
Title
Net Clinical Adverse Clinical Events (NACE) for 24 months
Description
A composite of all-cause of death, myocardial infarction (MI), stent thrombosis, stroke, or BARC type 2, 3, or 5 bleeding
Time Frame
upto 2 years after randomization
Secondary Outcome Measure Information:
Title
All-cause death
Time Frame
upto 2 years after randomization
Title
Cardiovascular death
Time Frame
upto 2 years after randomization
Title
Myocardial infarction
Time Frame
upto 2 years after randomization
Title
Stent thrombosis
Time Frame
upto 2 years after randomization
Title
Ischemia-driven target vessel revascularization
Time Frame
upto 2 years after randomization
Title
Any revascularization
Time Frame
upto 2 years after randomization
Title
Stroke
Time Frame
upto 2 years after randomization
Title
Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding
Time Frame
upto 2 years after randomization
Title
Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding
Time Frame
upto 2 years after randomization
Title
Bleeding Academic Research Consortium (BARC) type 2 bleeding
Time Frame
upto 2 years after randomization
Title
Bleeding Academic Research Consortium (BARC) type 3 bleeding
Time Frame
upto 2 years after randomization
Title
Bleeding Academic Research Consortium (BARC) type 5 bleeding
Time Frame
upto 2 years after randomization
Title
All-cause death, myocardial infarction, or stroke
Time Frame
upto 2 years after randomization
Title
Cardiovascular death, myocardial infarction, stent thrombosis, or stroke
Time Frame
upto 2 years after randomization
Title
All-cause death, myocardial infarction, stent thrombosis, stroke, or BARC type 3 or 5 bleeding
Time Frame
upto 2 years after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients > 18 years old Patients who previously underwent percutaneous coronary intervention with drug-eluting stent implantation 12 months (± 3 months) ago. At least one high risk characteristics of ischemic events High risk patients Acute coronary syndrome Previous history of cerebrovascular accidents Previous history of peripheral artery intervention Heart failure Diabetes mellitus requiring medication Chronic kidney disease (regardless of requirement of renal replacement therapy) High risk lesions Left main disease Multivessel disease, 2- or 3- vessels Bifurcation lesions requiring 2 or more stents Chronic total occlusion In-stent restenosis Graft lesions Diffuse long lesion requiring stent(s) with total stent length ≥28 mm Lesion at small sized vessel requiring stent(s) with stent diameter ≤2.5 mm Calcified lesions requiring atherectomy Exclusion Criteria: Patients > 80 years old Pregnant women or women with potential childbearing Life expectancy < 1 year Refusal or inability to understand of informed consent Patients eligible to long-term anticoagulation therapy Patients with major bleeding events in previous 3 months before randomization
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Byeong-Keuk Kim
Phone
02-2228-8465
Email
kimbk@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Byeong-Keuk Kim
Organizational Affiliation
Severance Cardiovascular Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Byeong-Keuk Kim
Phone
02-2228-8465
Email
kimbk@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD
No

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Tailored Anti-platelet Therapy After DES Implantation in High-risk Patients

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