Appropriate Duration of Anti-Platelet straTegy in Patients With Advance Chronic Kidney Disease After New Generation Drug Eluting Stents (ADAPT-CKD)

Study Overview
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Brief Summary
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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
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Prospective, open label, multicenter randomized clinical trial

Official Title
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Appropriate Duration of Anti-Platelet straTegy in Patients With Advance Chronic Kidney Disease After New Generation Drug Eluting Stents (ADAPT-CKD)

Conditions
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Chronic Kidney Diseases

Intervention / Treatment
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* Drug: dual anti-platelet therapy at least 6 months
* Drug: dual anti-platelet therapy 3months or less


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 19 years old Chronic Renal Failure Stage IIIb, IV, V (CKD-EPI eGFR <45 / <30 / <15 or dialysis) Patients treated with a new generation drug eluting stent. Patients who signed consent form Exclusion Criteria: Over 85 years old 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 Patients who need oral anticoagulant Pregnant women or women of childbearing age Life expectancy is less than 1 year Patients with a history of intracranial bleeding Moderate to severe hepatic impairment (Child-Pugh class B or C)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 84 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: dual anti-platelet therapy at least 6 months<br> | Drug: dual anti-platelet therapy at least 6 months<br>* 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.<br>|
| Experimental: dual anti-platelet therapy 3months or less<br> | Drug: dual anti-platelet therapy 3months or less<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Net Clinical adverse event (NACE) | Net Clinical adverse event (NACE) : all cause death, myocardial infarction, stent thrombosis, stroke, major bleeding (BARC 3,5) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of Each component of NACE | NACE : all cause or Cardiac death, myocardial infarction, stent thrombosis (definite, probable, possible), stroke (non-ischemic, ischemic), major bleeding (BARC 3,5) | 1 year | 
| The rate of key secondary efficacy endpoint : Major Efficacy end points | Cardiac death, myocardial infarction, stent thrombosis (definite or probable), stroke | 1 year | 
| The rate of key secondary safety endpoint : Major safety end points | BARC bleeding (2,3,5), Fatal bleeding or 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 (stable angina vs. acute coronary syndrome) |  | 1 year | 
| The 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anti-platlet therapy, chronic kidney disease, new generation drug eluting stents