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

Primary Purpose

Chronic Kidney Diseases

Status

Recruiting

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

dual anti-platelet therapy at least 6 months

dual anti-platelet therapy 3months or less

About this trial

This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring anti-platlet therapy, chronic kidney disease, new generation drug eluting stents

Eligibility Criteria

19 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Over 19 years old
Chronic Renal Failure Stage IIIb, IV, V (CKD-EPI eGFR <45 / <30 / <15 or dialysis)
Patients treated with a new generation drug eluting stent.
Patients who signed consent form

Exclusion Criteria:

Over 85 years old
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
Patients who need oral anticoagulant
Pregnant women or women of childbearing age
Life expectancy is less than 1 year
Patients with a history of intracranial bleeding
Moderate to severe hepatic impairment (Child-Pugh class B or C)

Sites / Locations

Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

dual anti-platelet therapy at least 6 months

dual anti-platelet therapy 3months or less

Arm Description

Outcomes

Primary Outcome Measures

Net Clinical adverse event (NACE)

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

Secondary Outcome Measures

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)

The rate of key secondary efficacy endpoint : Major Efficacy end points

Cardiac death, myocardial infarction, stent thrombosis (definite or probable), stroke

The rate of key secondary safety endpoint : Major safety end points

BARC bleeding (2,3,5), Fatal bleeding or intracranial hemorrhage

The rate of Target lesion revascularization

The rate of Target vessel revascularization

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)

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)

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)

Full Information

NCT ID

NCT04708587

First Posted

December 31, 2020

Last Updated

July 28, 2021

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT04708587

Brief Title

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

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Recruiting

Study Start Date

March 23, 2021 (Actual)

Primary Completion Date

March 2025 (Anticipated)

Study Completion Date

March 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Kidney Diseases

Keywords

anti-platlet therapy, chronic kidney disease, new generation drug eluting stents

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

900 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

dual anti-platelet therapy at least 6 months

Arm Type

Active Comparator

Arm Title

dual anti-platelet therapy 3months or less

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

dual anti-platelet therapy at least 6 months

Intervention 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.

Intervention Type

Drug

Intervention Name(s)

dual anti-platelet therapy 3months or less

Intervention 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.

Primary Outcome Measure Information:

Title

Net Clinical adverse event (NACE)

Description

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

Time Frame

1 year

Secondary Outcome Measure Information:

Title

The rate of Each component of NACE

Description

NACE : all cause or Cardiac death, myocardial infarction, stent thrombosis (definite, probable, possible), stroke (non-ischemic, ischemic), major bleeding (BARC 3,5)

Time Frame

1 year

Title

The rate of key secondary efficacy endpoint : Major Efficacy end points

Description

Cardiac death, myocardial infarction, stent thrombosis (definite or probable), stroke

Time Frame

1 year

Title

The rate of key secondary safety endpoint : Major safety end points

Description

BARC bleeding (2,3,5), Fatal bleeding or intracranial hemorrhage

Time Frame

1 year

Title

The rate of Target lesion revascularization

Time Frame

1 year

Title

The rate of Target vessel revascularization

Time Frame

1 year

Title

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)

Time Frame

1 year

Title

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)

Time Frame

1 year

Title

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)

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

84 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Over 19 years old Chronic Renal Failure Stage IIIb, IV, V (CKD-EPI eGFR <45 / <30 / <15 or dialysis) Patients treated with a new generation drug eluting stent. Patients who signed consent form Exclusion Criteria: Over 85 years old 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 Patients who need oral anticoagulant Pregnant women or women of childbearing age Life expectancy is less than 1 year Patients with a history of intracranial bleeding Moderate to severe hepatic impairment (Child-Pugh class B or C)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jung-Sun Kim, MD, PhD, FESC

Phone

82)-2)-2228-8457

KJS1218@yuhs.ac

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jung-Sun Kim, MD, PhD, FESC

Organizational Affiliation

Severance Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine

City

Seoul

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jung-Sun Kim, MD, PhD, FESC

Phone

82)-2)-2228-8457

KJS1218@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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