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)

Sponsors

Commanditaire principal: Yonsei University

La source Yonsei University
Bref résumé

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.

Description détaillée

Prospective, open label, multicenter randomized clinical trial

Situation globale Not yet recruiting
Date de début February 2021
Date d'achèvement March 2026
Date d'achèvement principale March 2025
Phase N/A
Type d'étude Interventional
Résultat primaire
Mesure Plage de temps
Net Clinical adverse event (NACE) 1 year
Résultat secondaire
Mesure Plage de temps
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
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État
Intervention

Type d'intervention: Drug

Nom de l'intervention: dual anti-platelet therapy at least 6 months

La 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.

Étiquette du groupe d'armements: dual anti-platelet therapy at least 6 months

Type d'intervention: Drug

Nom de l'intervention: dual anti-platelet therapy 3months or less

La 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.

Étiquette du groupe d'armements: dual anti-platelet therapy 3months or less

Admissibilité

Critères:

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)

Le sexe: All

Âge minimum: 19 Years

Âge maximum: 84 Years

Volontaires en santé: No

Officiel général
Nom de famille Rôle Affiliation
Jung-Sun Kim, MD, PhD, FESC Principal Investigator Severance Hospital
Contact général

Nom de famille: Jung-Sun Kim, MD, PhD, FESC

Téléphone: 82)-2)-2228-8457

Email: [email protected]

Emplacement
Établissement: Contact: Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine Jung-Sun Kim, MD, PhD, FESC 82)-2)-2228-8457 [email protected]
Pays d'implantation

Korea, Republic of

Date de vérification

January 2021

Partie responsable

Type: Sponsor

Mots clés
A un accès étendu No
Parcourir l'état
Nombre d'armes 2
Groupe d'armes

Étiquette: dual anti-platelet therapy at least 6 months

Type: Active Comparator

Étiquette: dual anti-platelet therapy 3months or less

Type: Experimental

Données patient No
Informations sur la conception de l'étude

Allocation: Randomized

Modèle d'intervention: Parallel Assignment

Objectif principal: Treatment

Masquage: None (Open Label)

La source: ClinicalTrials.gov