← Back to Clinical Trials
Recruiting Phase 3 NCT03789916

SAPT Versus DAPT in Incomplete Revascularization After CABG

Trial Parameters

Condition Coronary Artery Disease
Sponsor Campus Bio-Medico University
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 800
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2019-01-02
Completion 2021-08-01
Interventions
Ticagreloracetylsalicylic acid

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 DAPT will be continued for 12 months, and ticagrelor will be withdrawn thereafter.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.

Eligibility Criteria

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

Related Trials