Ticagrelor 90 MG: Ticagrelor 90 mg twice daily taken orally for one month
Low-dose aspirin: 75-150 mg once daily taken orally
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
Hierarchical composite of time to death, stroke, myocardial infarction, repeat revascularization and any graft failure. — 1 year 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
Trial sites (22)
Facility
City
Region
Status
Englewood Hospital
Englewood
New Jersey
Recruiting
NewYork-Presbyterian: Queens Hospital
Flushing
New York
Recruiting
Weill Cornell Medicine
New York
New York
Recruiting
Medical University Innsbruck
Innsbruck
Innsbruck
Recruiting
Medical University Graz
Graz
Austria
Recruiting
Johannes Kepler University Linz
Linz
Austria
Recruiting
Medical University of Vienna
Vienna
Austria
Recruiting
University of Ottawa Heart Institute
Ottawa
Ontario
Not Yet Recruiting
Ruijin Hospital: Shanghai Jiao Tong University School of Medicine
Shanghai
China
Recruiting
Jilin Heart Hospital
Changchun
Jilian
Recruiting
Beijing Anzhen Hospital
Beijing
China
Recruiting
Center China Fuwai Hospital
Beijing
China
Recruiting
University Hospital of Düsseldorf
Düsseldorf
Germany
Recruiting
Westdeutsches Herz- und Gefäßzentrum Essen, Universität Duisburg-Essen
Essen
Germany
Not Yet Recruiting
Klinik für Herz- und Gefäßchirurgie - Universitäts-Herzzentrum Freiburg - Bad Krozingen
Freiburg im Breisgau
Germany
Recruiting
University Hospital Giessen
Giessen
Germany
Recruiting
Jena University Hospital
Jena
Germany
Recruiting
LMU Klinikum Campus Großhadern
München
Germany
Not Yet Recruiting
Robert-Bosch-Krankenhaus Stuttgart
Stuttgart
Germany
Not Yet Recruiting
Sahlgrenska University Hospital
Gothenburg
Sweden
Recruiting
Sahlgrenska University Hospital Sweden
Gothenburg
Sweden
Not Yet Recruiting
Skåne University Hospital
Malmö
Sweden
Recruiting
More Weill Medical College of Cornell University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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