|

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

RECRUITINGN/ASponsored by Yonsei University
Actively Recruiting
PhaseN/A
SponsorYonsei University
Started2023-08-16
Est. completion2027-05
Eligibility
Age19 Years – 80 Years
Healthy vol.Accepted

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.

Eligibility

Age: 19 Years – 80 YearsHealthy volunteers accepted
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

Conditions2

Coronary Artery DiseaseHeart Disease

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.