Chronic Coronary Disease
Conditions
Brief 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.
Detailed description
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.
Interventions
DRUGTicagrelor 90 MG
Ticagrelor 90 mg twice daily taken orally for one month
DRUGLow-dose aspirin
75-150 mg once daily taken orally
Sponsors
Canadian Institutes of Health Research (CIHR)
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hierarchical composite of time to death, stroke, myocardial infarction, Bleeding Academic Research Consortium (BARC) type 3 bleeding, 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 BARC 3 bleeding 5. Time to coronary revascularization 6. Presence of graft failure at 12-month imaging follow-up |
| 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 | 5 years | 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 |
| Hierarchical composite of time to death, stroke, myocardial infarction, BARC type 3 bleeding, repeat revascularization and 5-year time-averaged SAQ-7 QoL score. | 5 years | 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 |
Countries
Austria, Canada, China, Germany, Sweden, United States
Contacts
Primary ContactTrisha Ali-Shaw
Outcome results
None listed