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Recruiting NCT04708587

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

No phase Interventional Chronic Kidney Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: dual anti-platelet therapy at least 6 months, dual anti-platelet therapy 3months or less.
Who it may be relevant to
Registry conditions: Chronic Kidney Diseases. Basic parameters: 19 years — 84 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Drug dual 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.
  • Drug dual 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.

Primary outcome measures

  • Net Clinical adverse event (NACE) [Time frame: 1 year]
Secondary outcome measures (12)
  • The rate of Each component of NACE [Time frame: 1 year]
  • The rate of Cardiovascular death [Time frame: 1 year]
  • The rate of Major adverse cardiovascular events (MACE) [Time frame: 1 year]
  • The rate of Composite ischemic outcomes [Time frame: 1 year]
  • The rate of major or clinically relevant nonmajor bleeding [Time frame: 1 year]
  • Fatal bleeding [Time frame: 1 year]
  • Intracranial hemorrhage [Time frame: 1 year]
  • The rate of Target lesion revascularization [Time frame: 1 year]
  • The rate of Target vessel revascularization [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 1 year]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medic — Seoul

Publications

  • Jin IT, Lee SH, Yun KH, Kim W, Shin S, Jang JY, Cho DK, Cha JJ, Kang TS, Lee JH, Cho YK, Heo JH, Ahn SG, Lee J, Lee YJ, Lee SJ, Hong SJ, Ahn CM, Kim BK, Ko YG, Choi D, Hong MK, Jang Y, Kim JS. Optimal antiplatelet strategy in patients with advanced chronic kidney disease undergoing drug-eluting stent implantation: Design and rationale of the randomized ADAPT-CKD trial. Am Heart J. 2026 Aug;298:107 PMID 41932491

Identifiers

NCT: NCT04708587 · 1-2020-0073

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗