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Clinical Trial Details

Trial ID: L0034
Source ID: NCT04708587
Associated Drug: Dual Anti-Platelet Therapy At Least 6 Months
Title: Appropriate Duration of Anti-Platelet straTegy in Patients With Advance Chronic Kidney Disease After New Generation Drug Eluting Stents (ADAPT-CKD)
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Chronic Kidney Diseases
Interventions: DRUG: dual anti-platelet therapy at least 6 months|DRUG: dual anti-platelet therapy 3months or less
Outcome Measures: 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|The rate of key secondary efficacy endpoint : Major Efficacy end points, Cardiac death, myocardial infarction, stent thrombosis (definite or probable), stroke, 1 year|The rate of key secondary safety endpoint : Major safety end points, BARC bleeding (2,3,5), Fatal bleeding or intracranial hemorrhage, 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
Sponsor/Collaborators: Sponsor: Yonsei University
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 900
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-03-23
Completion Date: 2028-03-13
Results First Posted:
Last Update Posted: 2024-10-23
Locations: Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT04708587