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

Not Applicable

Recruiting

• Conditions: Chronic Kidney Diseases
• Interventions: Drug: dual anti-platelet therapy at least 6 months; Drug: dual anti-platelet therapy 3months or less

• Registration Number: NCT04708587
• Lead Sponsor: Yonsei University

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.

Detailed Description

Prospective, open label, multicenter randomized clinical trial

Study Timeline

• Study First Submitted: 2020-12-31
• Study First Submitted QC: 2021-01-11
• Study First Posted: 2021-01-14
• Study Start: 2021-03-23
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-22
• Last Update Posted: 2024-10-23
• Primary Completion: 2027-03-13
• Study Completion: 2028-03-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 900

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dual anti-platelet therapy at least 6 months	dual anti-platelet therapy at least 6 months	-
dual anti-platelet therapy 3months or less	dual anti-platelet therapy 3months or less	-

Primary Outcome Measures

Name	Time	Method
Net Clinical adverse event (NACE)	1 year	Net Clinical adverse event (NACE) : all cause death, myocardial infarction, stent thrombosis, stroke, major bleeding (BARC 3,5)

Secondary Outcome Measures

Name	Time	Method
The rate of Each component of NACE	1 year	NACE : all cause or Cardiac death, myocardial infarction, stent thrombosis (definite, probable, possible), stroke (non-ischemic, ischemic), major bleeding (BARC 3,5)
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 key secondary efficacy endpoint : Major Efficacy end points	1 year	Cardiac death, myocardial infarction, stent thrombosis (definite or probable), stroke
The rate of Target lesion revascularization	1 year
The rate of key secondary safety endpoint : Major safety end points	1 year	BARC bleeding (2,3,5), Fatal bleeding or intracranial hemorrhage
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 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

Trial Locations

Locations (1)

Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of