Status:
RECRUITING
SAPT Versus DAPT in Incomplete Revascularization After CABG
Lead Sponsor:
Campus Bio-Medico University
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 surg...
Eligibility Criteria
Inclusion
- patients undergoing CABG, ± cardiopulmonary bypass, ± any associated cardiac procedures (valve replacement,...)
- incomplete myocardial revascularization, defined by anatomic or functional criteria
- obtained informed consent
Exclusion
- 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- surgical treatment requiring DAPT withdrawn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
Key Trial Info
Start Date :
January 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT03789916
Start Date
January 2 2019
End Date
December 31 2026
Last Update
July 21 2022
Active Locations (1)
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1
Università Campus Bio-Medico di Roma
Rome, Italy, 00128