SAPT Versus DAPT in Incomplete Revascularization After CABG (SDAT-IRC)
Primary Purpose
Coronary Artery Disease
Status
Recruiting
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Ticagrelor
acetylsalicylic acid
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring coronary artery bypass grafting, incomplete revascularization, coronary artery disease, dual antiplatelet therapy
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- surgical treatment requiring DAPT withdrawn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
Sites / Locations
- Università Campus Bio-Medico di RomaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DAPT
SAPT
Arm Description
"Dual antiplatelet therapy": acetylsalicylic acid 100 mg/die + ticagrelor 90 mg bis in die
"Single antiplatelet therapy": acetylsalicylic acid 100 mg/die
Outcomes
Primary Outcome Measures
Cardiac-related mortality
Secondary Outcome Measures
Mortality
Overall mortality and non-cardiac-related mortality
Major adverse cardiac and cerebrovascular events (MACCEs)
cardiac-related mortality, myocardial infarction, repeated vessel revascularization, hospitalization for heart failure, major arrhythmias, stroke
Major adverse hemorrhagic events (MAHEs)
stroke, gastrointestinal bleeding, life-threatening bleeding
Full Information
NCT ID
NCT03789916
First Posted
December 27, 2018
Last Updated
July 19, 2022
Sponsor
Campus Bio-Medico University
1. Study Identification
Unique Protocol Identification Number
NCT03789916
Brief Title
SAPT Versus DAPT in Incomplete Revascularization After CABG
Acronym
SDAT-IRC
Official Title
Single Versus Dual Antiplatelet Therapy in Patients With Incomplete Revascularization After Coronary Artery Bypass Graft Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 2, 2019 (Actual)
Primary Completion Date
August 1, 2021 (Actual)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Campus Bio-Medico University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
coronary artery bypass grafting, incomplete revascularization, coronary artery disease, dual antiplatelet therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DAPT
Arm Type
Experimental
Arm Description
"Dual antiplatelet therapy": acetylsalicylic acid 100 mg/die + ticagrelor 90 mg bis in die
Arm Title
SAPT
Arm Type
Active Comparator
Arm Description
"Single antiplatelet therapy": acetylsalicylic acid 100 mg/die
Intervention Type
Drug
Intervention Name(s)
Ticagrelor
Other Intervention Name(s)
Brilique
Intervention Description
90 mg bis in die
Intervention Type
Drug
Intervention Name(s)
acetylsalicylic acid
Intervention Description
100 mg die
Primary Outcome Measure Information:
Title
Cardiac-related mortality
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Mortality
Description
Overall mortality and non-cardiac-related mortality
Time Frame
5 years
Title
Major adverse cardiac and cerebrovascular events (MACCEs)
Description
cardiac-related mortality, myocardial infarction, repeated vessel revascularization, hospitalization for heart failure, major arrhythmias, stroke
Time Frame
5 years
Title
Major adverse hemorrhagic events (MAHEs)
Description
stroke, gastrointestinal bleeding, life-threatening bleeding
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio Nenna, MD
Phone
+393337014743
Email
a.nenna@unicampus.it
First Name & Middle Initial & Last Name or Official Title & Degree
Massimo Chello, MD
Email
m.chello@unicampus.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Massimo Chello, MD
Organizational Affiliation
Università Campus Bio-Medico di Roma, Rome, Italy
Official's Role
Study Chair
Facility Information:
Facility Name
Università Campus Bio-Medico di Roma
City
Rome
ZIP/Postal Code
00128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Nenna, MD
Phone
+393337014743
Email
a.nenna@unicampus.it
First Name & Middle Initial & Last Name & Degree
Massimo Chello, MD
Email
m.chello@unicampus.it
First Name & Middle Initial & Last Name & Degree
Antonio Nenna, MD
First Name & Middle Initial & Last Name & Degree
Massimo Chello, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
27665400
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.
Results Reference
result
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SAPT Versus DAPT in Incomplete Revascularization After CABG
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