SAPT Versus DAPT in Incomplete Revascularization After CABG

Coronary Artery Disease Clinical Trial

— SDAT-IRC  

Official title:

Single Versus Dual Antiplatelet Therapy in Patients With Incomplete Revascularization After Coronary Artery Bypass Graft Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03789916
• Other study ID #: 72.18
• Status: Recruiting
• Phase: Phase 3
• Start date: January 2, 2019
• Est. completion date: December 31, 2026

Study information

• Verified date: July 2022
• Source: Campus Bio-Medico University
• Contact: Antonio Nenna, MD
• Phone: +393337014743
• Email: a.nenna[@]unicampus.it
• Is FDA regulated: No
• Study type: Interventional

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 DAPT will be continued for 12 months, and ticagrelor will be withdrawn thereafter.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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 31, 2026
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Ticagrelor
90 mg bis in die
• acetylsalicylic acid
100 mg die

Locations

Country	Name	City	State
Italy	Università Campus Bio-Medico di Roma	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Campus Bio-Medico University

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac-related mortality		5 years
Secondary	Mortality	Overall mortality and non-cardiac-related mortality	5 years
Secondary	Major adverse cardiac and cerebrovascular events (MACCEs)	cardiac-related mortality, myocardial infarction, repeated vessel revascularization, hospitalization for heart failure, major arrhythmias, stroke	5 years
Secondary	Major adverse hemorrhagic events (MAHEs)	stroke, gastrointestinal bleeding, life-threatening bleeding	5 years