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- Essai clinique NCT07796217
Comparison of Clopidogrel-based Antiplatelet Agent Treatment and Aspirin Plus Low Dose Rivaroxaban Therapy (OACART)
Optimal Strategy for Treatment of Atherosclerotic Cardiovascular Disease - Comparison of Clopidogrel-based Antiplatelet Agent Treatment Versus Aspirin Plus Low Dose Rivaroxaban Therapy
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Rupture of atherosclerotic plaques and resulting thrombotic or embolic events can lead to myocardial infarction, stroke, and death. Particularly after vascular interventions such as percutaneous coronary intervention, stent implantation, or peripheral vascular interventions, it takes more than a year for the damaged endothelial cells to heal completely, leading to frequent thrombotic complications. In addition, clinically undiagnosed atrial fibrillation, stroke caused by thrombosis formation due to venous damage, myocardial infarction, deep vein thrombosis, and pulmonary embolism may occur. Therefore, drug therapy to prevent thrombosis is necessary for these patients, and many studies have been conducted to determine the optimal treatment.
Dual antiplatelet therapy (DAPT) with aspirin and clopidogrel is essential for treating patients after percutaneous coronary intervention (PCI). DAPT can minimize ischemic events not only in stent lesions but also in non-reperfused lesions of the coronary artery. However, DAPT increases the risk of bleeding, so a treatment strategy is needed to minimize ischemic events while reducing the risk of bleeding by using dual antiplatelet therapy for a short time after the procedure, administering antiplatelet drugs differently depending on the bleeding risk. In particular, in patients at high risk of bleeding (HBR), the side effects of bleeding due to long-term antiplatelet therapy are closely related to long-term survival, making this issue even more important. Compared to traditional aspirin use, the use of clopidogrel has been reported to reduce mortality, myocardial infarction, stroke, and hospitalization due to acute coronary artery disease while reducing bleeding complications.
In addition, a study has reported that combining low-dose anticoagulants with aspirin as a thromboprophylactic agent for stable atherosclerotic patients who were previously treated only with antiplatelet drugs reduces mortality and has superior effects on the prevention of myocardial infarction and stroke compared to aspirin alone. Aspirin and low-dose rivaroxaban combination therapy has been approved for use in patients with multivessel CAD who are over 65 years of age and have experienced acute myocardial infarction for more than one year, as well as patients with peripheral arterial disease (PAD) (history of PTA or bypass, history of foot/leg amputation, intermittent claudication with ABI <0.9, or over 50% stenosis in peripheral arteries, or over 50% stenosis in coronary arteries or previous coronary stent implantation) who have one of the two conditions: a history of acute myocardial infarction for over one year or multivessel CAD.
Ultimately, studies comparing clopidogrel and low-dose rivaroxaban and aspirin combination therapy in similar patient populations have shown the superiority of each treatment strategy, but no studies have compared the two treatment strategies. If clopidogrel monotherapy is more convenient to take, has better compliance, and is not less effective than low-dose rivaroxaban and aspirin combination therapy, it may be considered as a more convenient treatment strategy for many patients.
Type d'étude
Inscription (Estimé)
Phase
- Phase 4
Contacts et emplacements
Coordonnées de l'étude
- Nom: Ju Seung Kwun, M.D
- Numéro de téléphone: +82 31 787 7841
- E-mail: jkwun0413@gmail.com
Sauvegarde des contacts de l'étude
- Nom: Chang-Hwan Yoon, M.D Ph.D
- Numéro de téléphone: +82 31 787 7052
- E-mail: changhwanyoon@gmail.com
Lieux d'étude
-
-
Gyeonggi-do
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Seongnam-si, Gyeonggi-do, Corée du Sud, 463-707
- Recrutement
- Seoul National Universtiy Bundang Hospital
-
Contact:
- Chang-Hwan Yoon, MD
- Numéro de téléphone: +82 31 787 7052
- E-mail: changhwanyoon@gmail.com
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Patients over 65 years of age who have experienced acute myocardial infarction and have multivessel coronary artery disease (CAD) that has been present for over one year
- Patients who have peripheral arterial disease (history of PTA or bypass, history of foot/leg amputation, intermittent claudication with ABI <0.9 or over 50% stenosis in peripheral arteries, or over 50% stenosis in coronary arteries or previous coronary stent implantation) and have a history of acute myocardial infarction for over one year or have one of the two conditions: multivessel CAD.
- Subject is able to verbally confirm understandings of risks, benefits and treatment, and he/she or his/her legally authorized representative provides written informed consent prior to study
Exclusion Criteria:
- History of serious hypersensitivity reactions to aspirin, clopidogrel, or prasugrel.
- Patients with coagulation disorders or liver diseases related to coagulation, as well as patients with moderate (Child Pugh B) and severe (Child Pugh C) liver dysfunction.
- Severe renal impairment with a creatinine clearance less than 15 mL/min.
- Patients who require long-term combination therapy with other anticoagulants such as unfractionated heparin (UFH), low molecular weight heparin (enoxaparin, dalteparin, etc.), heparinoids (fondaparinux, etc.), oral anticoagulants (warfarin, apixaban, dabigatran, etc.).
- In cases of active clinical bleeding at the time of study registration.
- Patients who require discontinuation of antiplatelet therapy for more than 3 months due to surgery or procedure
- Individuals with an expected lifespan of less than 3 years due to reasons other than cardiovascular disease.
- Concomitant use of the following contraindicated drugs: other P2Y12 inhibitors (prasugrel or ticagrelor); cytochrome P450 2C19 inhibitors (fluoxetine, fluvoxamine, or voriconazole); probenecid; high-dose methotrexate (≥15 mg/week); lithium.
- Pregnant or breastfeeding women.
- Inability to provide informed consent
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Combination of antiplatelet and low-dose anticoagulant agents
A group that maintains combined antiplatelet and anticoagulant therapy with aspirin and low-dose rivaroxaban
|
Combination of aspirin and low-dose rivaroxaban
Autres noms:
|
|
Comparateur actif: Conventional use of clopidogrel-based antiplatelet therapy with or without aspirin
A group that maintains clopidogrel-based antiplatelet therapy, with or without aspirin, at the clinician's discretion
|
Clopidogrel-based SAPT or DAPT at the clinician's discretion
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Patient oriented cardiac event
Délai: 36 months
|
All-cause death, any myocardial infarction, any stroke, any revascularization (coronary or peripheral disease), acute limb ischemia (including all major vascular amputations), any acute thromboembolism, and BARC classification ≥ 2
|
36 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Patient oriented cardiac event in CAD only group
Délai: 36 months
|
All-cause death, any myocardial infarction, any stroke, any revascularization (coronary or peripheral disease), acute limb ischemia (including all major vascular amputations), any acute thromboembolism, and BARC classification ≥ 2
|
36 months
|
|
Patient oriented cardiac event in PAD only group
Délai: 36 months
|
All-cause death, any myocardial infarction, any stroke, any revascularization (coronary or peripheral disease), acute limb ischemia (including all major vascular amputations), any acute thromboembolism, and BARC classification ≥ 2
|
36 months
|
|
Composite of MI, stroke or CV death
Délai: 36 months
|
Myocardial infarction, stroke or cardiovascular death measured by percent of participants with adverse events
|
36 months
|
|
Composite of MI, stroke or CV death in CAD only group
Délai: 36 months
|
Myocardial infarction, stroke or cardiovascular death measured by percent of coronary disease participants with adverse events
|
36 months
|
|
Composite of MI, stroke or CV death in CAD and PAD group
Délai: 36 months
|
Myocardial infarction, stroke or cardiovascular death measured by percent of all participants with adverse events
|
36 months
|
|
Patency of target lesion in PAD intervention group
Délai: 36 months
|
Measured by percent of participants undergone repeat PTA to the previous lesion
|
36 months
|
|
Composite of major thrombotic events
Délai: 36 months
|
Cardiovascular death, MI, ischemic stroke, stent thrombosis or acute limb ischemia, venous thromboembolism (Deep vein thrombosis or pulmonary embolism)
|
36 months
|
Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chercheur principal: In-Ho Chae, M.D Ph.D, Seoul National University Bundang Hospital
Publications et liens utiles
Publications générales
- Valgimigli M, Bueno H, Byrne RA, Collet JP, Costa F, Jeppsson A, Juni P, Kastrati A, Kolh P, Mauri L, Montalescot G, Neumann FJ, Petricevic M, Roffi M, Steg PG, Windecker S, Zamorano JL, Levine GN; ESC Scientific Document Group; ESC Committee for Practice Guidelines (CPG); ESC National Cardiac Societies. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS: The Task Force for dual antiplatelet therapy in coronary artery disease of the European Society of Cardiology (ESC) and of the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2018 Jan 14;39(3):213-260. doi: 10.1093/eurheartj/ehx419. No abstract available.
- Aboyans V, Ricco JB, Bartelink MEL, Bjorck M, Brodmann M, Cohnert T, Collet JP, Czerny M, De Carlo M, Debus S, Espinola-Klein C, Kahan T, Kownator S, Mazzolai L, Naylor AR, Roffi M, Rother J, Sprynger M, Tendera M, Tepe G, Venermo M, Vlachopoulos C, Desormais I; ESC Scientific Document Group. 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS): Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteriesEndorsed by: the European Stroke Organization (ESO)The Task Force for the Diagnosis and Treatment of Peripheral Arterial Diseases of the European Society of Cardiology (ESC) and of the European Society for Vascular Surgery (ESVS). Eur Heart J. 2018 Mar 1;39(9):763-816. doi: 10.1093/eurheartj/ehx095. No abstract available.
- Knuuti J, Wijns W, Saraste A, Capodanno D, Barbato E, Funck-Brentano C, Prescott E, Storey RF, Deaton C, Cuisset T, Agewall S, Dickstein K, Edvardsen T, Escaned J, Gersh BJ, Svitil P, Gilard M, Hasdai D, Hatala R, Mahfoud F, Masip J, Muneretto C, Valgimigli M, Achenbach S, Bax JJ; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes. Eur Heart J. 2020 Jan 14;41(3):407-477. doi: 10.1093/eurheartj/ehz425. No abstract available.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies vasculaires
- Processus pathologiques
- Maladies cardiaques
- Athérosclérose
- Artériosclérose
- Maladies artérielles occlusives
- Maladies vasculaires périphériques
- Maladie coronarienne
- Ischémie myocardique
- Conditions pathologiques, signes et symptômes
- Maladies cardiovasculaires
- Maladie artérielle périphérique
- Maladie de l'artère coronaire
- Hémorragie
- Composés de soufre
- Produits chimiques organiques
- Pyridines
- Composés hétérocycliques, 1 anneau
- Composés hétérocycliques
- Composés hétérocycliques, 2 anneaux
- Composés hétérocycliques, anneau fusionné
- Hydrocarbures
- Hydrocarbures, cyclique
- Hydrocarbures, aromatique
- Phénols
- Dérivés de benzène
- Morpholines
- Oxazines
- Thiophenes
- Salicylates
- Hydroxybenzoates
- Ticlopidine
- Thiénopyridines
- Clopidogrel
- Rivaroxaban
- Aspirine
- Biditer des protéines, humain
- 2'-deoxythymidylyl- (3'-5 ') - 2'-deoxyadénosine
Autres numéros d'identification d'étude
- B-2304-820-003
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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