SAPT Versus DAPT in Incomplete Revascularization After CABG
Single Versus Dual Antiplatelet Therapy in Patients With Incomplete Revascularization After Coronary Artery Bypass Graft Surgery
Campus Bio-Medico University
800 participants
Jan 2, 2019
INTERVENTIONAL
Conditions
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 DAPT will be continued for 12 months, and ticagrelor will be withdrawn thereafter.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.
Eligibility
Inclusion Criteria3
- patients undergoing CABG, ± cardiopulmonary bypass, ± any associated cardiac procedures (valve replacement,...)
- incomplete myocardial revascularization, defined by anatomic or functional criteria
- obtained informed consent
Exclusion Criteria20
- 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- surgical treatment requiring DAPT withdrawn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
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Interventions
90 mg bis in die
100 mg die
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT03789916