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

July 19, 2022 updated by: Antonio Nenna, MD, Campus Bio-Medico University

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

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 DAPT will be continued for 12 months, and ticagrelor will be withdrawn thereafter.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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

800

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Rome, Italy, 00128
        • Recruiting
        • Università Campus Bio-Medico di Roma
        • Contact:
        • Contact:
        • Principal Investigator:
          • Antonio Nenna, MD
        • Principal Investigator:
          • Massimo Chello, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: DAPT
"Dual antiplatelet therapy": acetylsalicylic acid 100 mg/die + ticagrelor 90 mg bis in die
Drug: Ticagrelor
90 mg bis in die
Other Names:
  • Brilique
Drug: acetylsalicylic acid
100 mg die
ACTIVE_COMPARATOR: SAPT
"Single antiplatelet therapy": acetylsalicylic acid 100 mg/die
Drug: acetylsalicylic acid
100 mg die

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cardiac-related mortality
Time Frame: 5 years
5 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Campus Bio-Medico University

Investigators

  • Study Chair: Massimo Chello, MD, Università Campus Bio-Medico di Roma, Rome, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 2, 2019

Primary Completion (ACTUAL)

August 1, 2021

Study Completion (ANTICIPATED)

December 31, 2026

Study Registration Dates

First Submitted

December 27, 2018

First Submitted That Met QC Criteria

December 28, 2018

First Posted (ACTUAL)

December 31, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 21, 2022

Last Update Submitted That Met QC Criteria

July 19, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 72.18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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