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

NCT04708587 | Recruiting DMC

• 1 other identifier: 1-2020-0073
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Kidney Diseases

Keywords

anti-platelet therapy; chronic kidney disease; new generation drug eluting stents

Outcome Measures

Primary Outcomes (1)

• Net Clinical adverse event (NACE)

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

  1 year

Secondary Outcomes (12)

• The rate of Each component of NACE

  1 year

• The rate of Cardiovascular death

  1 year

• The rate of Major adverse cardiovascular events (MACE)

  1 year

• The rate of Composite ischemic outcomes

  1 year

• The rate of major or clinically relevant nonmajor bleeding

  1 year

Study Arms (2)

dual anti-platelet therapy at least 6 months

ACTIVE COMPARATOR

Drug: dual anti-platelet therapy at least 6 months

dual anti-platelet therapy 3months or less

EXPERIMENTAL

Drug: dual anti-platelet therapy 3months or less

Interventions

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 at least 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.

dual anti-platelet therapy 3months or less

Eligibility Criteria

• Age: 19 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Dual Anti-Platelet Therapy

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy, Combination; Drug Therapy; Therapeutics

Study Officials

• Jung-Sun Kim, MD, PhD, FESC

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jung-Sun Kim, MD, PhD, FESC

CONTACT

82)-2)-2228-8457; KJS1218@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2020
• First Posted: January 14, 2021
• Study Start: March 23, 2021
• Primary Completion (Estimated): March 13, 2027
• Study Completion (Estimated): March 13, 2028
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)