SAPT Versus DAPT in Incomplete Revascularization After CABG (SDAT-IRC)

Campus Bio-Medico University of Rome

Status and phase: Enrolling; Phase 3

Conditions: Coronary Artery Disease

Treatments: Drug: acetylsalicylic acid; Drug: Ticagrelor

Study type: Interventional

Funder types: Other

Identifiers

NCT03789916

72.18

Details and patient eligibility

About

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 DAPT will be continued for 12 months, and ticagrelor will be withdrawn thereafter.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

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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• surgical treatment requiring DAPT withdrawn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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

800 participants in 2 patient groups

DAPT

Experimental group

Description:

"Dual antiplatelet therapy": acetylsalicylic acid 100 mg/die + ticagrelor 90 mg bis in die

Treatment:

Drug: acetylsalicylic acid

Drug: Ticagrelor

SAPT

Active Comparator group

Description:

"Single antiplatelet therapy": acetylsalicylic acid 100 mg/die

Treatment:

Drug: acetylsalicylic acid