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

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

Sponsors

Lead Sponsor: Yonsei University

Source 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

Overall Status Not yet recruiting
Start Date February 2021
Completion Date March 2026
Primary Completion Date March 2025
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Net Clinical adverse event (NACE) 1 year
Secondary Outcome
Measure Time Frame
The rate of Each component of NACE 1 year
The rate of key secondary efficacy endpoint : Major Efficacy end points 1 year
The rate of key secondary safety endpoint : Major safety end points 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
Enrollment 900
Condition
Intervention

Intervention Type: Drug

Intervention Name: dual anti-platelet therapy at least 6 months

Description: 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.

Arm Group Label: dual anti-platelet therapy at least 6 months

Intervention Type: Drug

Intervention Name: dual anti-platelet therapy 3months or less

Description: 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.

Arm Group Label: dual anti-platelet therapy 3months or less

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)

Gender: All

Minimum Age: 19 Years

Maximum Age: 84 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Jung-Sun Kim, MD, PhD, FESC Principal Investigator Severance Hospital
Overall Contact

Last Name: Jung-Sun Kim, MD, PhD, FESC

Phone: 82)-2)-2228-8457

Email: [email protected]

Location
Facility: Contact: Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine Jung-Sun Kim, MD, PhD, FESC 82)-2)-2228-8457 [email protected]
Location Countries

Korea, Republic of

Verification Date

January 2021

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: dual anti-platelet therapy at least 6 months

Type: Active Comparator

Label: dual anti-platelet therapy 3months or less

Type: Experimental

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov