Coronary Artery Disease
Conditions
Keywords
coronary artery bypass grafting, incomplete revascularization, coronary artery disease, dual antiplatelet therapy
Brief summary
The study aims to compare the efficacy of dual antiplatelet therapy (DAPT) over single antiplatelet therapy (SAPT) in patients with incomplete revascularization after coronary artery bypass graft surgery (CABG). Before hospital discharge, patients will be 1:1 randomized to SAPT (acetylsalicylic acid 100 mg/die) or DAPT (acetylsalicylic acid 100 mg/die + ticagrelor 90 mg bis in die). DAPT will be continued for 12 months, and ticagrelor will be withdrawn thereafter. Primary endpoint is the evaluation of cardiac-related mortality at 5 years from hospital discharge.
Interventions
DRUGTicagrelor
90 mg bis in die
DRUGacetylsalicylic acid
100 mg die
Sponsors
Campus Bio-Medico University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients undergoing CABG, ± cardiopulmonary bypass, ± any associated cardiac procedures (valve replacement,...) * incomplete myocardial revascularization, defined by anatomic or functional criteria * obtained informed consent
Exclusion criteria
* acute coronary syndrome \< 12 months from surgery * dual antiplatelet therapy at hospital admission * planned procedure to complete myocardial revascularization (e.g. hybrid approach) * intolerance / unable to take acetylsalicylic acid or ticagrelor * preoperative atrial fibrillation * impaired compliance * planned pregnancy * history of gastrointestinal bleeding * chronic kidney disease (eGFR \< 30 mL/min/1.73 m2) * chronic liver disease * severe heart failure at hospital admission * active malignancy * alcohol abuse * any clinical condition not compatible with the treatment Exit Criteria: * postoperative atrial fibrillation requiring anticoagulation * postoperative hemorrhagic events (stroke, GI bleeding) * occurrence of contraindications to acetylsalicylic acid or ticagrelor * surgical treatment requiring DAPT withdrawn * patient decision
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiac-related mortality | 5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 5 years | Overall mortality and non-cardiac-related mortality |
| Major adverse cardiac and cerebrovascular events (MACCEs) | 5 years | cardiac-related mortality, myocardial infarction, repeated vessel revascularization, hospitalization for heart failure, major arrhythmias, stroke |
| Major adverse hemorrhagic events (MAHEs) | 5 years | stroke, gastrointestinal bleeding, life-threatening bleeding |
Countries
Italy
Contacts
Primary ContactAntonio Nenna, MD
Backup ContactMassimo Chello, MD
Outcome results
None listed