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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)

Sponsor
Yonsei University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04708587
Collaborator
(none)
900
Enrollment
1
Location
2
Arms
59.3
Anticipated Duration (Months)
15.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: dual anti-platelet therapy at least 6 months
  • Drug: dual anti-platelet therapy 3months or less
 N/A

Detailed Description

Prospective, open label, multicenter randomized clinical trial

Study Design

Study Type:
Interventional
Anticipated Enrollment :
900 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Appropriate Duration of Anti-Platelet straTegy in Patients With Advance Chronic Kidney Disease After New Generation Drug Eluting Stents (ADAPT-CKD)
Actual Study Start Date :
Mar 23, 2021
Anticipated Primary Completion Date :
Mar 1, 2025
Anticipated Study Completion Date :
Mar 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: dual anti-platelet therapy at least 6 months

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.
Experimental: dual anti-platelet therapy 3months or less

Drug: 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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)

  2. The rate of key secondary efficacy endpoint : Major Efficacy end points [1 year]

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

  3. The rate of key secondary safety endpoint : Major safety end points [1 year]

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

  4. The rate of Target lesion revascularization [1 year]

  5. The rate of Target vessel revascularization [1 year]

  6. 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]

  7. 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]

  8. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 84 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine Seoul Korea, Republic of

Sponsors and Collaborators

  • Yonsei University

Investigators

  • Principal Investigator: Jung-Sun Kim, MD, PhD, FESC, Severance Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yonsei University
ClinicalTrials.gov Identifier:
NCT04708587
Other Study ID Numbers:
  • 1-2020-0073
First Posted:
Jan 14, 2021
Last Update Posted:
Jul 29, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yonsei University
anti-platlet therapy
chronic kidney disease
new generation drug eluting stents
Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic

Study Results

No Results Posted as of Jul 29, 2021