One-Month DAPT in CABG Patients

Study Overview
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Brief Summary
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The purpose of this study is to compare the effect of ticagrelor versus placebo in patients with chronic coronary disease undergoing coronary artery bypass grafting.

Detailed Description
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A multinational, randomized, double-blind, placebo-controlled trial to evaluate the effect of one-month ticagrelor twice daily in addition to low-dose aspirin on the incidence of death, myocardial infarction, stroke, repeat revascularization and graft failure in patients with chronic coronary disease undergoing coronary artery bypass grafting.

Official Title
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One Month Dual Antiplatelet Therapy With Ticagrelor in Coronary Artery Bypass Graft Patients

Conditions
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Chronic Coronary Disease

Intervention / Treatment
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* Drug: Ticagrelor 90 MG
* Drug: Ticagrelor placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ticagrelor 90 mg<br> | Drug: Ticagrelor 90 MG<br>* Ticagrelor 90 mg bd taken orally<br>|
| Placebo Comparator: Ticagrelor placebo<br> | Drug: Ticagrelor placebo<br>* Ticagrelor placebo bd taken orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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: Time to all-cause mortality Time to stroke Time to myocardial infarction Time to coronary revascularization Presence of graft failure at 12-month imaging follow-up or on unscheduled imaging prior to 12 month | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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: Time to all-cause mortality Time to stroke Time to myocardial infarction Time to BARC 3 bleeding Time to coronary revascularization 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: Time to all-cause mortality Time to stroke Time to myocardial infarction Time to coronary revascularization 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: Time to all-cause mortality Time to stroke Time to myocardial infarction Time to BARC 3 bleeding Time to coronary revascularization 5-year time-averaged disease-specific QOL (SAQ-7) score | 5 years |