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

NCT ID: NCT05936606

Last Updated: 2023-08-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 3434 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-16
• Study Completion Date: 2029-05-31

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Uniform Therapy

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

Group Type: ACTIVE_COMPARATOR

Clopidogrel monotherapy

Intervention Type: DRUG

Patients will receive clopidogrel monotherapy (75 mg qd) for 24 months after randomization, irrespective of PRU value or bleeding risk.

Tailored Therapy

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

Group Type: EXPERIMENTAL

Tailored anti-platelet therapy

Intervention Type: DRUG

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.

Interventions

Clopidogrel monotherapy

Patients will receive clopidogrel monotherapy (75 mg qd) for 24 months after randomization, irrespective of PRU value or bleeding risk.

Intervention Type: DRUG

Tailored anti-platelet therapy

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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Byeong-Keuk Kim

Role: PRINCIPAL_INVESTIGATOR

Severance Cardiovascular Hospital

Locations

Severance Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Byeong-Keuk Kim

Role: CONTACT

kimbk@yuhs.ac

02-2228-8465

Facility Contacts

Byeong-Keuk Kim

Role: primary

kimbk@yuhs.ac

02-2228-8465

Other Identifiers

4-2023-0175

Identifier Type: -

Identifier Source: org_study_id