Clinical trial NCT03789916: SAPT Versus DAPT in Incomplete Revascularization After CABG
Official title: Single Versus Dual Antiplatelet Therapy in Patients With Incomplete Revascularization After Coronary Artery Bypass Graft Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Coronary Artery Disease
Keywords: coronary artery bypass grafting
incomplete revascularization
coronary artery disease
dual antiplatelet therapy
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2018-12-31
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 DAPT will be continued for 12 months, and ticagrelor will be withdrawn thereafter.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 of contraindications to acetylsalicylic acid or ticagrelor
* surgical treatment requiring DAPT withdrawn
* patient decision

Primary outcomes:
measure: Cardiac-related mortality
timeFrame: 5 years
Secondary outcomes:
measure: Mortality
timeFrame: 5 years
measure: Major adverse cardiac and cerebrovascular events (MACCEs)
timeFrame: 5 years
measure: Major adverse hemorrhagic events (MAHEs)
timeFrame: 5 years
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Università Campus Bio-Medico di Roma
Study officials:
affiliation: Università Campus Bio-Medico di Roma, Rome, Italy
name: Massimo Chello, MD
role: STUDY_CHAIR
References:
citation: Spadaccio C, Nappi F, Nenna A, Beattie G, Chello M, Sutherland FW. Is it time to change how we think about incomplete coronary revascularization? Int J Cardiol. 2016 Dec 1;224:295-298. doi: 10.1016/j.ijcard.2016.09.055. Epub 2016 Sep 18.