Evaluating the safety and effectiveness of Onyx stents in elderly patients with coronary artery disease
Safety and Efficacy of 1-month Dual Antiplatelet Therapy in High Bleeding and Ischemic Risk Elderly Patients With Coronary Artery Disease After Implantation of Zotarolimus-eluting Coronary Stent System (Onyx Family, Medtronic, Minneapolis, MN); A Multicenter, Prospective, Observational Study
This study is testing if switching from two blood-thinning medications to one after using Onyx stents helps elderly patients with heart disease stay safe and healthy over a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 75 Years to 100 Years |
| Sex | All |
| Sponsor | Pusan National University Yangsan Hospital Academic / other |
| Locations | 1 site (Yangsan, Gyeongsangnam-do) |
| Trial ID | NCT06577896 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on elderly patients aged 75 years or older who are undergoing percutaneous coronary intervention with Onyx family drug-eluting stents. It aims to observe the safety and efficacy of transitioning from dual antiplatelet therapy to single therapy after one month of dual therapy. The study will monitor these patients for one year following the procedure to assess outcomes related to myocardial ischemia and coronary artery stenosis. The goal is to determine the best antiplatelet strategy for this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are elderly patients aged 75 years or older who have undergone coronary artery procedures with Onyx family stents and are able to take antiplatelet medications.
Not a fit: Patients with known hypersensitivity to antiplatelet medications or those with active bleeding conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for elderly patients with coronary artery disease, potentially reducing the risk of complications associated with prolonged dual antiplatelet therapy.
How similar studies have performed: While there have been studies on dual antiplatelet therapy, this specific approach focusing on elderly patients with Onyx stents is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 75 or more. * Eligible for interventional procedures. * Evidence of myocardial ischemia or coronary artery stenosis ≥ 50%. * Able to take antiplatelets for at least 1 months after the procedure. * Patients who underwent coronary artery procedures with ZES (Medtronic, Minneapolis, MN, Onyx™ family) stent. Exclusion Criteria: * The patient has a known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, zotarolimus, and contrast media (patients with documented sensitivity to contrast media which can be effectively premedicated with steroids and diphenhydramine \[eg, rash\] may be enrolled. Those with true anaphylaxis to prior contrast media, however, should not be enrolled). * Patients with active pathologic bleeding. * Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months. * History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia). * Noncardiac comorbid conditions are present with life expectancy \<1 year or that may result in protocol noncompliance (per site investigator\'s medical judgment). * Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
Where this trial is running
Yangsan, Gyeongsangnam-do
- Pusan National University Yangsan Hospital — Yangsan, Gyeongsangnam-do, South Korea (Recruiting)
Study contacts
- Principal investigator: Min Ku Chon, MD,PhD — Pusan National University Yangsan Hospital
- Study coordinator: Min Ku Chon, MD,PhD
- Email: chonmingu@gmail.com
- Phone: 82-10-2562-6258
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.