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

Lead Sponsor: Yonsei University

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.

Prospective, open label, multicenter randomized clinical trial

• Chronic Kidney Diseases

Intervention Type: Drug

Intervention Name: dual anti-platelet therapy at least 6 months

Description: 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.

Arm Group Label: dual anti-platelet therapy at least 6 months

Intervention Type: Drug

Intervention Name: dual anti-platelet therapy 3months or less

Description: 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.

Arm Group Label: dual anti-platelet therapy 3months or less

Criteria:

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)

Gender: All

Minimum Age: 19 Years

Maximum Age: 84 Years

Healthy Volunteers: No

Last Name: Jung-Sun Kim, MD, PhD, FESC

Phone: 82)-2)-2228-8457

Email: [email protected]

Korea, Republic of

January 2021

Type: Sponsor

• anti-platlet therapy
• chronic kidney disease
• new generation drug eluting stents

• Kidney Diseases
• Renal Insufficiency, Chronic

Label: dual anti-platelet therapy at least 6 months

Type: Active Comparator

Label: dual anti-platelet therapy 3months or less

Type: Experimental

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)