SAPT Versus DAPT in Incomplete Revascularization After CABG

Phase 3

Recruiting

• Conditions: Coronary Artery Disease
• Interventions: Drug: acetylsalicylic acid; Drug: Ticagrelor

• Registration Number: NCT03789916
• Lead Sponsor: Campus Bio-Medico University

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 DAPT will be continued for 12 months, and ticagrelor will be withdrawn thereafter.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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-27
• Study First Submitted QC: 2018-12-28
• Study First Posted: 2018-12-31
• Study Start: 2019-01-02
• Primary Completion: 2021-08-01
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-21
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

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• surgical treatment requiring DAPT withdrawn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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SAPT	acetylsalicylic acid	"Single antiplatelet therapy": acetylsalicylic acid 100 mg/die
DAPT	acetylsalicylic acid	"Dual antiplatelet therapy": acetylsalicylic acid 100 mg/die + ticagrelor 90 mg bis in die
DAPT	Ticagrelor	"Dual antiplatelet therapy": acetylsalicylic acid 100 mg/die + ticagrelor 90 mg bis in die

Primary Outcome Measures

Name	Time	Method
Cardiac-related mortality	5 years

Secondary Outcome Measures

Name	Time	Method
Major adverse hemorrhagic events (MAHEs)	5 years	stroke, gastrointestinal bleeding, life-threatening bleeding
Mortality	5 years	Overall mortality and non-cardiac-related mortality
Major adverse cardiac and cerebrovascular events (MACCEs)	5 years	cardiac-related mortality, myocardial infarction, repeated vessel revascularization, hospitalization for heart failure, major arrhythmias, stroke

Trial Locations

Locations (1)

Università Campus Bio-Medico di Roma; 🇮🇹 Rome, Italy