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

• Sponsor: Yonsei University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05936606
• Collaborator: (none)
• Enrollment: 3,434
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 70
• Patients Per Site Per Month: 49

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Drug: Clopidogrel monotherapy; Drug: Tailored anti-platelet therapy	N/A

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<213), clopidogrel monotherapy will be continued; for HPR patients (PRU≥213), dual antiplatelet therapy will be prescribed based on clinical diagnosis at the time of stent implantation. Patients with acute coronary syndrome at the time of coronary intervention will receive ticagrelor 60 mg twice daily with aspirin, while those with chronic coronary syndrome 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 based on the patient's risk level. The treatment assignment ratio is 1:1. The study period will be up to 24 months from the time of randomization.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 3434 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Patients will be assigned to receive either standard clopidogrel monotherapy or tailored antiplatelet therapy at 12 months after DES implantation.Patients will be assigned to receive either standard clopidogrel monotherapy or tailored antiplatelet therapy at 12 months after DES implantation.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Jul 1, 2023
• Anticipated Primary Completion Date: May 1, 2027
• Anticipated Study Completion Date: May 1, 2029

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Uniform Therapy Patients will continue clopidogrel monotherapy for 24 months from randomization, irrespective of their PRU measurement.	Drug: Clopidogrel monotherapy; Patients will receive clopidogrel monotherapy (75 mg qd) for 24 months after randomization, irrespective of PRU value or bleeding risk.
Experimental: Tailored Therapy Patients in the intervention arm will receive tailored anti-platelet therapy according to PRU and bleeding risk	Drug: Tailored anti-platelet therapy; In the tailored therapy arm, non-HPR (PRU<213) patients will continue clopidogrel mono-therapy until the end of the study at 24 months from randomization, while HPR (PRU≥213) patients will receive dual anti-platelet therapy according to the clinical diagnosis at the time of drug-eluting stent placement: ACS patients will receive ticagrelor 60 mg twice daily with aspirin, and CCS patients will receive clopidogrel with aspirin.

Outcome Measures

Primary Outcome Measures

1. Net Clinical Adverse Clinical Events (NACE) for 24 months [upto 2 years after randomization]

   A composite of all-cause of death, myocardial infarction (MI), stent thrombosis, stroke, or BARC type 2, 3, or 5 bleeding

Secondary Outcome Measures

1. All-cause death [upto 2 years after randomization]

2. Cardiovascular death [upto 2 years after randomization]

3. Myocardial infarction [upto 2 years after randomization]

4. Stent thrombosis [upto 2 years after randomization]

5. Ischemia-driven target vessel revascularization [upto 2 years after randomization]

6. Any revascularization [upto 2 years after randomization]

7. Stroke [upto 2 years after randomization]

8. Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding [upto 2 years after randomization]

9. Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding [upto 2 years after randomization]

10. Bleeding Academic Research Consortium (BARC) type 2 bleeding [upto 2 years after randomization]

11. Bleeding Academic Research Consortium (BARC) type 3 bleeding [upto 2 years after randomization]

12. Bleeding Academic Research Consortium (BARC) type 5 bleeding [upto 2 years after randomization]

13. All-cause death, myocardial infarction, or stroke [upto 2 years after randomization]

14. Cardiovascular death, myocardial infarction, stent thrombosis, or stroke [upto 2 years after randomization]

15. All-cause death, myocardial infarction, stent thrombosis, stroke, or BARC type 3 or 5 bleeding [upto 2 years after randomization]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 79 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Severance Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Yonsei University

Investigators

• Principal Investigator: Byeong-Keuk Kim, Severance Cardiovascular Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT05936606
• Other Study ID Numbers: 4-2023-0175
• First Posted: Jul 10, 2023
• Last Update Posted: Jul 10, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Yonsei University: Coronary artery disease; antiplatelet therapy; platelet reactivity
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Clopidogrel

Study Results

No Results Posted as of Jul 10, 2023