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 |
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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. |
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detaillierte Beschreibung | Prospective, open label, multicenter randomized clinical trial |
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Gesamtstatus | Not yet recruiting | ||||||||||||||||||
Anfangsdatum | February 2021 | ||||||||||||||||||
Fertigstellungstermin | March 2026 | ||||||||||||||||||
Primäres Abschlussdatum | March 2025 | ||||||||||||||||||
Phase | N/A | ||||||||||||||||||
Studientyp | Interventional | ||||||||||||||||||
Primärer Ausgang |
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Sekundäres Ergebnis |
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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 |
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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 |
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Insgesamt offiziell |
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Gesamtkontakt |
Nachname: Jung-Sun Kim, MD, PhD, FESC Telefon: 82)-2)-2228-8457 Email: [email protected] |
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Ort |
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Standort Länder |
Korea, Republic of |
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Überprüfungsdatum |
January 2021 |
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Verantwortliche Partei |
Art: Sponsor |
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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 |
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Patientendaten | No | ||||||||||||||||||
Studiendesign Info |
Zuweisung: Randomized Interventionsmodell: Parallel Assignment Hauptzweck: Treatment Maskierung: None (Open Label) |