Clinical trial NCT06577896: The Study to Evaluate the Safety and Efficacy of the Onyx Family
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2024-08-29
Enrollment: 500
Sex: ALL
Minimum age (years): 75
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who underwent percutaneous coronary intervention using Onyx family stents in those aged 75 years or older

Brief summary: Observation of the safety and efficacy of 1-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention using Onyx family stents in elderly patients aged 75 years or older

Detailed description: For elderly patients aged 75 years or older undergoing percutaneous coronary intervention with Onyx family drug-eluting stents, observe the safety and efficacy of transitioning from dual antiplatelet therapy to single therapy for one year after one month of dual antiplatelet therapy

Eligibility 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 \&lt;1 year or that may result in protocol noncompliance (per site investigator\&#39;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.

Primary outcomes:
measure: MACCE at 12 months after coronary artery intervention
timeFrame: 1 year after the procedure
Secondary outcomes:
measure: safety of procedures
timeFrame: 1 year after the procedure
measure: safety of procedures
timeFrame: 1 year after the procedure
measure: safety of procedures
timeFrame: 1 year after the procedure
measure: safety of procedures
timeFrame: 1 year after the procedure
measure: safety of procedures
timeFrame: 1 year after the procedure
measure: safety of procedures
timeFrame: 1 year after the procedure
measure: safety of procedures
timeFrame: 1 year after the procedure
measure: safety of procedures
timeFrame: 1 year after the procedure
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyeongsangnam-do
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Min Ku Chon, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: