One-Month DAPT in CABG Patients
Recruiting now · Phase 3
Conditions studied: Chronic Coronary Disease
In brief
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.
Key facts
- Study ID
- NCT05997693
- Run by
- Weill Medical College of Cornell University
- People needed
- 700
- Starts
- 2024-08-15
- Expected to finish
- 2031-01-01
- Last updated by the study team
- 2025-12-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Skåne University Hospital — Malmö, Sweden (enrolling)
- NewYork-Presbyterian: Queens Hospital — Flushing, New York, United States (enrolling)
- Weill Cornell Medicine — New York, New York, United States (enrolling)
- Medical University Innsbruck — Innsbruck, Innsbruck, Austria (enrolling)
- Medical University Graz — Graz, Austria (enrolling)
- Johannes Kepler University Linz — Linz, Austria (enrolling)
- Medical University of Vienna — Vienna, Austria (enrolling)
- Klinik für Herz- und Gefäßchirurgie - Universitäts-Herzzentrum Freiburg - Bad Krozingen — Freiburg im Breisgau, Germany (enrolling)
- University Hospital Giessen — Giessen, Germany (enrolling)
- Jena University Hospital — Jena, Germany (enrolling)
- Sahlgrenska University Hospital — Gothenburg, Sweden (enrolling)
- Englewood Hospital — Englewood, New Jersey, United States (enrolling)
- Ruijin Hospital: Shanghai Jiao Tong University School of Medicine — Shanghai, China, China (enrolling)
- Jilin Heart Hospital — Changchun, Jilian, China (enrolling)
- Beijing Anzhen Hospital — Beijing, China (enrolling)
- Center China Fuwai Hospital — Beijing, China (enrolling)
- University Hospital of Düsseldorf — Düsseldorf, Germany (enrolling)
- University of Ottawa Heart Institute — Ottawa, Ontario, Canada
- Sahlgrenska University Hospital Sweden — Gothenburg, Sweden
- Westdeutsches Herz- und Gefäßzentrum Essen, Universität Duisburg-Essen — Essen, Germany
- LMU Klinikum Campus Großhadern — München, Germany
- Robert-Bosch-Krankenhaus Stuttgart — Stuttgart, Germany
Full record on ClinicalTrials.gov
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