- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 4
Contatti e Sedi
Contatto studio
- Nome: Ju Seung Kwun, M.D
- Numero di telefono: +82 31 787 7841
- Email: jkwun0413@gmail.com
Backup dei contatti dello studio
- Nome: Chang-Hwan Yoon, M.D Ph.D
- Numero di telefono: +82 31 787 7052
- Email: changhwanyoon@gmail.com
Luoghi di studio
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Gyeonggi-do
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Seongnam-si, Gyeonggi-do, Corea del Sud, 463-707
- Reclutamento
- Seoul National Universtiy Bundang Hospital
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Contatto:
- Chang-Hwan Yoon, MD
- Numero di telefono: +82 31 787 7052
- Email: changhwanyoon@gmail.com
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Combination of antiplatelet and low-dose anticoagulant agents
A group that maintains combined antiplatelet and anticoagulant therapy with aspirin and low-dose rivaroxaban
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Combination of aspirin and low-dose rivaroxaban
Altri nomi:
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Comparatore attivo: 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
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Clopidogrel-based SAPT or DAPT at the clinician's discretion
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Patient oriented cardiac event
Lasso di tempo: 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
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36 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Patient oriented cardiac event in CAD only group
Lasso di tempo: 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
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36 months
|
|
Patient oriented cardiac event in PAD only group
Lasso di tempo: 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
|
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Composite of MI, stroke or CV death
Lasso di tempo: 36 months
|
Myocardial infarction, stroke or cardiovascular death measured by percent of participants with adverse events
|
36 months
|
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Composite of MI, stroke or CV death in CAD only group
Lasso di tempo: 36 months
|
Myocardial infarction, stroke or cardiovascular death measured by percent of coronary disease participants with adverse events
|
36 months
|
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Composite of MI, stroke or CV death in CAD and PAD group
Lasso di tempo: 36 months
|
Myocardial infarction, stroke or cardiovascular death measured by percent of all participants with adverse events
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36 months
|
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Patency of target lesion in PAD intervention group
Lasso di tempo: 36 months
|
Measured by percent of participants undergone repeat PTA to the previous lesion
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36 months
|
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Composite of major thrombotic events
Lasso di tempo: 36 months
|
Cardiovascular death, MI, ischemic stroke, stent thrombosis or acute limb ischemia, venous thromboembolism (Deep vein thrombosis or pulmonary embolism)
|
36 months
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: In-Ho Chae, M.D Ph.D, Seoul National University Bundang Hospital
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
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Completamento primario (Stimato)
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Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie vascolari
- Processi patologici
- Malattie cardiache
- Aterosclerosi
- Arteriosclerosi
- Malattie arteriose occlusive
- Malattie vascolari periferiche
- Malattia coronarica
- Ischemia miocardica
- Condizioni patologiche, segni e sintomi
- Malattia cardiovascolare
- Malattia arteriosa periferica
- Disfunsione dell'arteria coronaria
- Emorragia
- Composti di zolfo
- Prodotti chimici organici
- Piridine
- Composti eterociclici, 1-anello
- Composti eterociclici
- Composti eterociclici, 2 anelli
- Composti eterociclici, anello fuso
- Idrocarburi
- Idrocarburi, ciclici
- Idrocarburi, aromatici
- Fenoli
- Derivati di benzene
- Morfoline
- Ossazine
- Tiofenes
- Salicilati
- Idrossibenzoati
- Ticlopidina
- Tienopiridine
- Clopidogrel
- Rivaroxaban
- Aspirina
- Proteina di offerta, umano
- 2'-deoxythymidylyl- (3'-5 ')-2'-deossyadenosina
Altri numeri di identificazione dello studio
- B-2304-820-003
Piano per i dati dei singoli partecipanti (IPD)
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