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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
Campus Bio-Medico University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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  • surgical treatment requiring DAPT withdrawn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

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

First Posted
December 27, 2018
Last Updated
July 19, 2022
Sponsor
Campus Bio-Medico University
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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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