RecruitingNot ApplicableNCT04708587

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


Sponsor

Yonsei University

Enrollment

900 participants

Start Date

Mar 23, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 19 YearsMax Age: 84 Years

Inclusion Criteria4

  • 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 Criteria7

  • 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)

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.


Locations(1)

Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine

Seoul, South Korea

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NCT04708587


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