Chronic Kidney Diseases
Conditions
Keywords
anti-platelet therapy, chronic kidney disease, new generation drug eluting stents
Brief summary
The purpose of this prospective randomized clinical trial is to compare the clinical outcomes according to the duration of aspirin and clopidogrel or prasugrel with dual anti-platelet therapy after percutaneous coronary intervention in patients with advanced chronic kidney disease using a new generation drug eluting stents.
Detailed description
Prospective, open label, multicenter randomized clinical trial
Interventions
DRUGdual anti-platelet therapy at least 6 months
Patients enrolled in dual antiplatelets at least 6 months arm would be administered with aspirin 100mg plus clopidogrel 75mg or prasugrel 10mg once daily for at least 6 months after randomization. Clopidogrel or prasugrel should be maintained after 6 months.
DRUGdual anti-platelet therapy 3months or less
Patient enrolled in the dual antiplatelet therapy less than 3 months arm would be administered with aspirin 100mg plus clopidogrel 75mg or prasugrel 10mg once daily for less than 3 months after randomization. After 3 months clopidogrel or prasugrel should be maintained.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 84 Years
Healthy volunteers
No
Inclusion criteria
1. Over 19 years old 2. Chronic Renal Failure Stage IIIb, IV, V (CKD-EPI eGFR \<45 / \<30 / \<15 or dialysis) 3. Patients treated with a new generation drug eluting stent. 4. Patients who signed consent form
Exclusion criteria
1. Over 85 years old 2. Patients with high risk of bleeding 1) History of hemorrhagic stroke 2) Stroke, dementia or central nervous system damage within 1 year 3) Head trauma or brain surgery within 6 months 4) Tumor in the skull 5) If aortic dissection is suspected 6) Internal bleeding within 6 weeks 7) In case of active bleeding or bleeding disorder 8) In case of major surgery, trauma or bleeding within 3 weeks 3. Patients who need oral anticoagulant 4. Pregnant women or women of childbearing age 5. Life expectancy is less than 1 year 6. Patients with a history of intracranial bleeding 7. Moderate to severe hepatic impairment (Child-Pugh class B or C)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Net Clinical adverse event (NACE) | 1 year | A composite of all cause death, myocardial infarction, stent thrombosis, stroke, major bleeding (BARC 3,5) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The rate of Each component of NACE | 1 year | all cause death, myocardial infarction, stent thrombosis, stroke, major bleeding (BARC 3,5) |
| The rate of Cardiovascular death | 1 year | — |
| The rate of Major adverse cardiovascular events (MACE) | 1 year | A composite of cardiovascular death, myocardial infarction, stent thrombosis or target vessel revascularization |
| The rate of Composite ischemic outcomes | 1 year | A composite of cardiovascular death, myocardial infarction, stent thrombosis or ischemic stroke |
| The rate of major or clinically relevant nonmajor bleeding | 1 year | BARC type 2,3,5 bleeding |
| Fatal bleeding | 1 year | — |
| Intracranial hemorrhage | 1 year | — |
| The rate of Target lesion revascularization | 1 year | — |
| The rate of Target vessel revascularization | 1 year | — |
| The rate of Subgroup analysis of primary endpoint, key secondary efficacy, safety endpoint and, revascularization according to the CKD stage (lllb vs. IV or V) | 1 year | — |
| The rate of Subgroup analysis of primary endpoint, key secondary efficacy, safety endpoint and, revascularization according to the clinical presentation (chronic coronary syndrome vs. acute coronary syndrome) | 1 year | — |
| he rate of Subgroup analysis of primary endpoint, key secondary efficacy, safety endpoint and, revascularization according to the type of Stent (polymer-free vs. durable-polymer) | 1 year | — |
Countries
South Korea
Contacts
CONTACTJung-Sun Kim, MD, PhD, FESC
PRINCIPAL_INVESTIGATORJung-Sun Kim, MD, PhD, FESC
Severance Hospital
Outcome results
None listed