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

NCT05936606 | Recruiting DMC

• 1 other identifier: 4-2023-0175
• Study Type: interventional
• Target: 3,434
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease; antiplatelet therapy; platelet reactivity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• All-cause death

  upto 2 years after randomization

• Cardiovascular death

  upto 2 years after randomization

• Myocardial infarction

  upto 2 years after randomization

• Stent thrombosis

  upto 2 years after randomization

• Ischemia-driven target vessel revascularization

  upto 2 years after randomization

Study Arms (2)

Uniform Therapy

ACTIVE COMPARATOR

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

Drug: Clopidogrel monotherapy

Tailored Therapy

EXPERIMENTAL

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

Drug: Tailored anti-platelet therapy

Interventions

Clopidogrel monotherapy DRUG

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

Uniform Therapy

Tailored anti-platelet therapy 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.

Tailored Therapy

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Byeong-Keuk Kim

  Severance Cardiovascular Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Byeong-Keuk Kim

CONTACT

02-2228-8465; kimbk@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be assigned to receive either standard clopidogrel monotherapy or tailored antiplatelet therapy at 12 months after DES implantation.

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: July 10, 2023
• Study Start: August 16, 2023
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2029
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)