Trial Radar IA | ||
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Lo studio clinico NCT05997693 (ODIN) per Chronic Coronary Disease è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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One-Month DAPT in CABG Patients (ODIN) Fase III 700
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La sperimentazione clinica NCT05997693 (ODIN) è uno studio interventistico di Fase III volto a esaminare la prevenzione per Chronic Coronary Disease, attualmente in arruolamento. Avviato il 15 agosto 2024, prevede di arruolare 700 partecipanti. Sotto la guida di Weill Medical College of Cornell University, dovrebbe concludersi entro il 1 gennaio 2031. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 22 dicembre 2025.
Sommario breve
The purpose of this study is to compare the effect of ticagrelor plus low-dose aspirin versus low-dose aspirin alone in patients with chronic coronary disease undergoing coronary artery bypass grafting.
Descrizione dettagliata
A multinational, randomized trial to evaluate the effect of one-month of ticagrelor plus low-dose aspirin, versus low-dose aspirin alone, on the incidence of death, myocardial infarction, stroke, repeat revascularization and graft failure in patients with chronic coronary disease undergoing coronary artery bypass grafting.
Titolo ufficiale
One Month Dual Antiplatelet Therapy With Ticagrelor in Coronary Artery Bypass Graft Patients
Patologie
Chronic Coronary DiseasePubblicazioni
Articoli scientifici e documenti di ricerca pubblicati su questo studio clinico:Altri ID dello studio
- ODIN
- 23-06026202
- 2023-506613-22 (Numero EudraCT)
- 488058 (Altro numero di finanziamento) (Canadian Institutes of Health Research (CIHR))
Numero NCT
Data di inizio (effettiva)
2024-08-15
Ultimo aggiornamento pubblicato
2025-12-22
Data di completamento (stimata)
2031-01
Arruolamento (previsto)
700
Tipo di studio
Interventistico
FASE
Fase III
Stato
In arruolamento
Scopo principale
Prevenzione
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleTicagrelor 90 mg + Low-Dose Aspirin | Ticagrelor 90 MG Ticagrelor 90 mg twice daily taken orally for one month Low-dose aspirin 75-150 mg once daily taken orally |
Comparatore attivoLow-Dose Aspirin Alone | Low-dose aspirin 75-150 mg once daily taken orally |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Hierarchical composite of time to death, stroke, myocardial infarction, repeat revascularization and any graft failure. | This is a composite endpoint to be compared between groups in a hierarchical order using the win ratio method. The following hierarchy is pre-specified:
1. Time to all-cause mortality
2. Time to stroke
3. Time to myocardial infarction
4. Time to coronary revascularization
5. Presence of graft failure at 12-month imaging follow-up or on unscheduled imaging prior to 12 month | 1 year |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Hierarchical composite of time to death, stroke, myocardial infarction, Bleeding Academic Research Consortium (BARC) type 3 bleeding, repeat revascularization and any graft failure. | This is a composite endpoint to be compared between groups in a hierarchical order using the win ratio method. The following hierarchy is pre-specified:
1. Time to all-cause mortality
2. Time to stroke
3. Time to myocardial infarction
4. Time to BARC 3 bleeding
5. Time to coronary revascularization
6. Presence of graft failure at 12-month imaging follow-up | 1 year |
Hierarchical composite of time to death, stroke, myocardial infarction, repeat revascularization and 5-year time-averaged disease-specific (Seattle Angina Questionnaire [SAQ]-7) quality of life (QoL) score | This is a composite endpoint to be compared between groups in a hierarchical order using the win ratio method. The following hierarchy is pre-specified:
1. Time to all-cause mortality
2. Time to stroke
3. Time to myocardial infarction
4. Time to coronary revascularization
5. 5-year time-averaged disease-specific QOL (SAQ-7) score | 5 years |
Hierarchical composite of time to death, stroke, myocardial infarction, BARC type 3 bleeding, repeat revascularization and 5-year time-averaged SAQ-7 QoL score. | This is a composite endpoint to be compared between groups in a hierarchical order using the win ratio method. The following hierarchy is pre-specified:
1. Time to all-cause mortality
2. Time to stroke
3. Time to myocardial infarction
4. Time to BARC 3 bleeding
5. Time to coronary revascularization
6. 5-year time-averaged disease-specific QOL (SAQ-7) score | 5 years |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
- Age ≥18 years
- Elective first-time CABG with use of ≥1 saphenous vein graft;
- Ability to sign informed consent and comply with all study procedures, including follow-up for at least 5 years.
Any indication for dual antiplatelet therapy, including
- Acute/recent (within 1 year) ACS (NSTE-ACS or STEMI)
- Recent PCI requiring continuation of dual antiplatelet therapy after CABG
Current or anticipated use of oral anticoagulation;
Paroxysmal, persistent or permanent atrial fibrillation;
Any concomitant cardiac or non-cardiac procedure;
Planned cardiac or non-cardiac surgery within one year;
Preoperative end-organ dysfunction (dialysis, moderate to severe liver failure, respiratory failure), cancer or other non-cardiac comorbidity with a life expectancy <5 years;
Inability to use the saphenous vein;
Contraindications to the use of aspirin;
Contraindications to the use of ticagrelor, including
- Known hypersensitivity to ticagrelor
- Active pathological bleeding (including, but not limited to gastrointestinal or intracranial bleeding)
- History of intracranial hemorrhage
- Concomitant therapy with strong CYP3A4 inhibitors (eg ketoconazole, clarithromycin, nefazodone, ritonavir, atazanavir)
Inability to undergo coronary computed tomographic angiography (CCTA);
Participating in another investigational device or drug study;
Women of childbearing potential
Any major perioperative complication including, but not limited to, stroke, TIA, MI, CABG-related bleeding (BARC type 4), sepsis.
Weill Medical College of Cornell UniversityCanadian Institutes of Health Research (CIHR)Contatti principali dello studio
Contatto: Trisha Ali-Shaw, 646-962-8281, [email protected]
22 Centri dello studio in 6 paesi
New Jersey
Englewood Hospital, Englewood, New Jersey, 07631, United States
Molly Schultheis, MD, Contatto, 201-894-5670, [email protected]
Molly Schultheis, MD, Investigatore principale
In arruolamento
New York
NewYork-Presbyterian: Queens Hospital, Flushing, New York, 11355, United States
Charles A Mack, MD, Contatto, 718-670-2400, [email protected]
Charles A Mack, MD, Investigatore principale
In arruolamento
Weill Cornell Medicine, New York, New York, 10065, United States
Mario Gaudino, MD PhD, Contatto, +1 212 746 1815, [email protected]
Mario Gaudino, MD PhD, Investigatore principale
In arruolamento
Innsbruck
Medical University Innsbruck, Innsbruck, Innsbruck, 6020, Austria
Elfriede Ruttmann-Ulmer, Contatto, 0043 512 504 80808, [email protected]
Elfriede Ruttmann-Ulmer, Investigatore principale
In arruolamento
Medical University Graz, Graz, Austria
Günther Laufer, Contatto, 0043-316-385-82820, [email protected]
Günther Laufer, MD, Investigatore principale
In arruolamento
Johannes Kepler University Linz, Linz, Austria
Andreas Zierer, Contatto, 43 (0)57680 832136, [email protected]
Andreas Zierer, Investigatore principale
In arruolamento
Medical University of Vienna, Vienna, 1090, Austria
Sigrid Sandner, MD, MSCE, Contatto, 0043 1 40400 6989, [email protected]
Sigrid Sandner, MD, MSCE, Investigatore principale
In arruolamento
Ontario
University of Ottawa Heart Institute, Ottawa, Ontario, K1Y 4W7, Canada
Marc Ruel, MD, MPH, Contatto, [email protected]
Marc Ruel, MD, MPH, Investigatore principale
Non ancora in arruolamento
China
Ruijin Hospital: Shanghai Jiao Tong University School of Medicine, Shanghai, China, 200023, China
Qiang Zhao, MD, Contatto, [email protected]
Qiang Zhao, MD, Investigatore principale
In arruolamento
Jilian
Jilin Heart Hospital, Changchun, Jilian, China
Massimo Lemma, MD, PhD, Contatto, 18644936793, [email protected]
Massimo Lemma, MD, PhD, Investigatore principale
In arruolamento
Beijing Anzhen Hospital, Beijing, 100029, China
Ran Dong, Contatto, +86-139-1041-0620, [email protected]
Ran Dong, Investigatore principale
In arruolamento
Center China Fuwai Hospital, Beijing, China
Zhaoyun Cheng, Contatto, +86 13903712068, [email protected]
Zhaoyun Cheng, Investigatore principale
In arruolamento
University Hospital of Düsseldorf, Düsseldorf, Germany
Alexander Assmann, Contatto, +49-(0)211-81-18331, [email protected]
Alexander Assmann, Investigatore principale
In arruolamento
Westdeutsches Herz- und Gefäßzentrum Essen, Universität Duisburg-Essen, Essen, Germany
Matthias Thielmann, Contatto
Matthias Thielmann, Investigatore principale
Non ancora in arruolamento
Klinik für Herz- und Gefäßchirurgie - Universitäts-Herzzentrum Freiburg - Bad Krozingen, Freiburg im Breisgau, Germany
Alicja Zientara, Contatto
Martin Czerny, Investigatore principale
In arruolamento
University Hospital Giessen, Giessen, 35043, Germany
Andreas Böning, Contatto, 0641-985-56242, [email protected]
Andreas Böning, Investigatore principale
In arruolamento
Jena University Hospital, Jena, Germany
Torsten Doenst, MD, Contatto
Contatto, 49 3641 9322901, [email protected]
Torsten Doenst, MD, Investigatore principale
In arruolamento
LMU Klinikum Campus Großhadern, München, Germany
Christian Hagl, Contatto
Christian Hagl, Investigatore principale
Non ancora in arruolamento
Robert-Bosch-Krankenhaus Stuttgart, Stuttgart, Germany
Marc Albert, Contatto
Marc Albert, Investigatore principale
Non ancora in arruolamento
Sahlgrenska University Hospital, Gothenburg, 413 45, Sweden
Anders Jeppsson, MD, PhD, Contatto, 0046-31-3427515, [email protected]
Anders Jeppsson, MD, PhD, Investigatore principale
In arruolamento
Sahlgrenska University Hospital Sweden, Gothenburg, Sweden
Bjorn Redfors, MD, PhD, Contatto
Bjorn Redfors, MD, PhD, Investigatore principale
Non ancora in arruolamento
Skåne University Hospital, Malmo, 214 28, Sweden
Igor Zindovic, MD, Contatto, 0046-46-175288, [email protected]
Igor Zindovic, MD, Investigatore principale
In arruolamento