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)

Sponsoren

Hauptsponsor: Yonsei University

Quelle Yonsei University
Kurze Zusammenfassung

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.

detaillierte Beschreibung

Prospective, open label, multicenter randomized clinical trial

Gesamtstatus Not yet recruiting
Anfangsdatum February 2021
Fertigstellungstermin March 2026
Primäres Abschlussdatum March 2025
Phase N/A
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
Net Clinical adverse event (NACE) 1 year
Sekundäres Ergebnis
Messen Zeitfenster
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
Einschreibung 900
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: dual anti-platelet therapy at least 6 months

Beschreibung: 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.

Armgruppenetikett: dual anti-platelet therapy at least 6 months

Interventionsart: Drug

Interventionsname: dual anti-platelet therapy 3months or less

Beschreibung: 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.

Armgruppenetikett: dual anti-platelet therapy 3months or less

Teilnahmeberechtigung

Kriterien:

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)

Geschlecht: All

Mindestalter: 19 Years

Maximales Alter: 84 Years

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Jung-Sun Kim, MD, PhD, FESC Principal Investigator Severance Hospital
Gesamtkontakt

Nachname: Jung-Sun Kim, MD, PhD, FESC

Telefon: 82)-2)-2228-8457

Email: [email protected]

Ort
Einrichtung: Kontakt: Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine Jung-Sun Kim, MD, PhD, FESC 82)-2)-2228-8457 [email protected]
Standort Länder

Korea, Republic of

Überprüfungsdatum

January 2021

Verantwortliche Partei

Art: Sponsor

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Anzahl der Waffen 2
Armgruppe

Etikette: dual anti-platelet therapy at least 6 months

Art: Active Comparator

Etikette: dual anti-platelet therapy 3months or less

Art: Experimental

Patientendaten No
Studiendesign Info

Zuweisung: Randomized

Interventionsmodell: Parallel Assignment

Hauptzweck: Treatment

Maskierung: None (Open Label)

Quelle: ClinicalTrials.gov