Clinical trial NCT04708587: Appropriate Duration of Anti-Platelet straTegy in Patients With Advance Chronic Kidney Disease After New Generation Drug Eluting Stents (ADAPT-CKD)
Official title: Appropriate Duration of Anti-Platelet straTegy in Patients With Advance Chronic Kidney Disease After New Generation Drug Eluting Stents (ADAPT-CKD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Kidney Diseases
Keywords: anti-platlet therapy
chronic kidney disease
new generation drug eluting stents
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 900
Sex: ALL
Minimum age (years): 19
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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)

Primary outcomes:
measure: Net Clinical adverse event (NACE)
timeFrame: 1 year
Secondary outcomes:
measure: The rate of Each component of NACE
timeFrame: 1 year
measure: The rate of key secondary efficacy endpoint : Major Efficacy end points
timeFrame: 1 year
measure: The rate of key secondary safety endpoint : Major safety end points
timeFrame: 1 year
measure: The rate of Target lesion revascularization
timeFrame: 1 year
measure: The rate of Target vessel revascularization
timeFrame: 1 year
measure: 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)
timeFrame: 1 year
measure: 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)
timeFrame: 1 year
measure: 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)
timeFrame: 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Study officials:
affiliation: Severance Hospital
name: Jung-Sun Kim, MD, PhD, FESC
role: PRINCIPAL_INVESTIGATOR
References: