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

Chronic Kidney Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04708587
• Other study ID #: 1-2020-0073
• Status: Recruiting
• Phase: N/A
• Start date: March 23, 2021
• Est. completion date: March 2026

Study information

• Verified date: July 2021
• Source: Yonsei University
• Contact: Jung-Sun Kim, MD, PhD, FESC
• Phone: 82)-2)-2228-8457
• Email: KJS1218[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Prospective, open label, multicenter randomized clinical trial

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: March 2026
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 84 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	The rate of key secondary efficacy endpoint : Major Efficacy end points	Cardiac death, myocardial infarction, stent thrombosis (definite or probable), stroke	1 year
Secondary	The rate of key secondary safety endpoint : Major safety end points	BARC bleeding (2,3,5), Fatal bleeding or intracranial hemorrhage	1 year
Secondary	The rate of Target lesion revascularization		1 year
Secondary	The rate of Target vessel revascularization		1 year
Secondary	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
Secondary	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
Secondary	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