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 (Anticipated): 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

• Korea, Republic of
  • Seoul, Korea, Republic of
    • 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
• Genders Eligible for Study: All

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)	Net Clinical adverse event (NACE) : 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 Each component of NACE	NACE : all cause or Cardiac death, myocardial infarction, stent thrombosis (definite, probable, possible), stroke (non-ischemic, ischemic), major bleeding (BARC 3,5)	1 year
The rate of key secondary efficacy endpoint : Major Efficacy end points	Cardiac death, myocardial infarction, stent thrombosis (definite or probable), stroke	1 year
The rate of key secondary safety endpoint : Major safety end points	BARC bleeding (2,3,5), Fatal bleeding or intracranial hemorrhage	1 year
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 (stable angina vs. acute coronary syndrome)		1 year
The 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

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 (Anticipated): March 1, 2025
• Study Completion (Anticipated): March 1, 2026

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): July 29, 2021
• Last Update Submitted That Met QC Criteria: July 28, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: chronic kidney disease; anti-platlet therapy; new generation drug eluting stents
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• 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