Personalized anti-platelet therapy for high-risk patients after stent placement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of a tailored anti-platelet therapy strategy for high-risk patients who have undergone drug-eluting stent (DES) placement. Participants will be randomly assigned to either continue standard clopidogrel monotherapy or receive personalized treatment based on their platelet reactivity. The intervention aims to optimize antiplatelet therapy beyond 12 months post-stenting, particularly for those with high platelet reactivity. The study will monitor outcomes over a period of up to 24 months.

Why it matters

Who can join: the full rules

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

Where it's running

• Severance Hospital
  Seoul, South Korea Recruiting

Study contacts

• Principal investigator: Byeong-Keuk Kim — Severance Cardiovascular Hospital
• Study coordinator: Byeong-Keuk Kim
• Email: kimbk@yuhs.ac
• Phone: 02-2228-8465

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.