SAPT Versus DAPT in Incomplete Revascularization After CABG
Recruiting now · Phase 3
Conditions studied: Coronary Artery Disease
In brief
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 DAPT will be continued for 12 months, and ticagrelor will be withdrawn thereafter.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.
Key facts
- Study ID
- NCT03789916
- Run by
- Campus Bio-Medico University
- People needed
- 800
- Starts
- 2019-01-02
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2022-07-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- patients undergoing CABG, ± cardiopulmonary bypass, ± any associated cardiac procedures (valve replacement,...)
- incomplete myocardial revascularization, defined by anatomic or functional criteria
- obtained informed consent
You may not qualify if…
- 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- surgical treatment requiring DAPT withdrawn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
Where it is running
- Università Campus Bio-Medico di Roma — Rome, Italy (enrolling)
Full record on ClinicalTrials.gov
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