NCT03789916

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 DAPT will be continued for 12 months, and ticagrelor will be withdrawn thereafter.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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for phase_3 coronary-artery-disease

Timeline
7mo left

Started Jan 2019

Longer than P75 for phase_3 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Jan 2019Dec 2026

First Submitted

Initial submission to the registry

December 27, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 31, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

January 2, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
5.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

July 21, 2022

Status Verified

July 1, 2022

Enrollment Period

2.6 years

First QC Date

December 27, 2018

Last Update Submit

July 19, 2022

Conditions

Coronary Artery Disease

Keywords

coronary artery bypass graftingincomplete revascularizationcoronary artery diseasedual antiplatelet therapy

Outcome Measures

Primary Outcomes (1)

  • Cardiac-related mortality

    5 years

Secondary Outcomes (3)

  • Mortality

    5 years

  • Major adverse cardiac and cerebrovascular events (MACCEs)

    5 years

  • Major adverse hemorrhagic events (MAHEs)

    5 years

Study Arms (2)

DAPT

EXPERIMENTAL

"Dual antiplatelet therapy": acetylsalicylic acid 100 mg/die + ticagrelor 90 mg bis in die

Drug: TicagrelorDrug: acetylsalicylic acid

SAPT

ACTIVE COMPARATOR

"Single antiplatelet therapy": acetylsalicylic acid 100 mg/die

Drug: acetylsalicylic acid

Interventions

TicagrelorDRUG

90 mg bis in die

Also known as: Brilique
DAPT
acetylsalicylic acidDRUG

100 mg die

DAPTSAPT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing CABG, ± cardiopulmonary bypass, ± any associated cardiac procedures (valve replacement,...)
  • incomplete myocardial revascularization, defined by anatomic or functional criteria
  • obtained informed consent

You may not qualify if:

  • 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:
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Università Campus Bio-Medico di Roma

Rome, 00128, Italy

RECRUITING

Related 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.

    PMID: 27665400RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

TicagrelorAspirin

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

AdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesSalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Massimo Chello, MD

    Università Campus Bio-Medico di Roma, Rome, Italy

    STUDY CHAIR

Central Study Contacts

Antonio Nenna, MD

CONTACT

+393337014743a.nenna@unicampus.it

Massimo Chello, MD

CONTACT

m.chello@unicampus.it

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiovascular Surgery

Study Record Dates

First Submitted

December 27, 2018

First Posted

December 31, 2018

Study Start

January 2, 2019

Primary Completion

August 1, 2021

Study Completion (Estimated)

December 31, 2026

Last Updated

July 21, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF, CSR

Locations

IT(1)