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NCT Number: NCT04708587

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

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.

Recruiting

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Key information

Age range

19 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Seoul, South Korea

Location status: Recruiting

Location contact

Jung-Sun Kim, MD, PhD, FESC

CONTACT

[email protected]

82)-2)-2228-8457

About this study

Prospective, open label, multicenter randomized clinical trial

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

dual anti-platelet therapy at least 6 months

Drug

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.

dual anti-platelet therapy 3months or less

Drug

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 outcomes

  1. Net Clinical adverse event (NACE)

    Time frame: 1 year

    A composite of all cause death, myocardial infarction, stent thrombosis, stroke, major bleeding (BARC 3,5)

Secondary outcomes

  1. The rate of Each component of NACE

    Time frame: 1 year

    all cause death, myocardial infarction, stent thrombosis, stroke, major bleeding (BARC 3,5)

  2. The rate of Cardiovascular death

    Time frame: 1 year

  3. The rate of Major adverse cardiovascular events (MACE)

    Time frame: 1 year

    A composite of cardiovascular death, myocardial infarction, stent thrombosis or target vessel revascularization

  4. The rate of Composite ischemic outcomes

    Time frame: 1 year

    A composite of cardiovascular death, myocardial infarction, stent thrombosis or ischemic stroke

  5. The rate of major or clinically relevant nonmajor bleeding

    Time frame: 1 year

    BARC type 2,3,5 bleeding

  6. Fatal bleeding

    Time frame: 1 year

  7. Intracranial hemorrhage

    Time frame: 1 year

  8. The rate of Target lesion revascularization

    Time frame: 1 year

  9. The rate of Target vessel revascularization

    Time frame: 1 year

  10. 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

  11. 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

  12. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Jung-Sun Kim, MD, PhD, FESC

CONTACT

[email protected]

82)-2)-2228-8457

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2021
Primary completion
2027
Study completion
2028
First posted
Jan 14, 2021
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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