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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Diseases
• Intervention / Treatment: Drug: dual anti-platelet therapy at least 6 months; Drug: dual anti-platelet therapy 3months or less

Detailed Description

Prospective, open label, multicenter randomized clinical trial

• Study Type: Interventional
• Enrollment (Estimated): 900
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jung-Sun Kim, MD, PhD, FESC; Phone Number: 82)-2)-2228-8457; Email: KJS1218@yuhs.ac

Study Locations

• South Korea
  • Seoul, South Korea
    • Recruiting
    • Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
    • Contact: Jung-Sun Kim, MD, PhD, FESC; Phone Number: 82)-2)-2228-8457; Email: KJS1218@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 84 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: dual anti-platelet therapy at least 6 months	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.
Experimental: dual anti-platelet therapy 3months or less	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Net Clinical adverse event (NACE)	A composite of all cause death, myocardial infarction, stent thrombosis, stroke, major bleeding (BARC 3,5)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of Target lesion revascularization		1 year
The rate of Target vessel revascularization		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)		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)		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)		1 year
The rate of Each component of NACE	all cause death, myocardial infarction, stent thrombosis, stroke, major bleeding (BARC 3,5)	1 year
The rate of Cardiovascular death		1 year
The rate of Major adverse cardiovascular events (MACE)	A composite of cardiovascular death, myocardial infarction, stent thrombosis or target vessel revascularization	1 year
The rate of Composite ischemic outcomes	A composite of cardiovascular death, myocardial infarction, stent thrombosis or ischemic stroke	1 year
The rate of major or clinically relevant nonmajor bleeding	BARC type 2,3,5 bleeding	1 year
Fatal bleeding		1 year
Intracranial hemorrhage		1 year

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Jung-Sun Kim, MD, PhD, FESC, Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2021
• Primary Completion (Estimated): March 13, 2027
• Study Completion (Estimated): March 13, 2028

Study Registration Dates

• First Submitted: December 31, 2020
• First Submitted That Met QC Criteria: January 11, 2021
• First Posted (Actual): January 14, 2021

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 18, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: chronic kidney disease; anti-platelet therapy; new generation drug eluting stents
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Therapeutics; Drug Therapy; Drug Therapy, Combination; Dual Anti-Platelet Therapy
• Other Study ID Numbers: 1-2020-0073

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No