NCT04783701

Brief Summary

The purpose of this study is to compare the presence of graft patency in single aspirin vs dual anti platelet therapy (DAPT) treatment including ticagrelor in patients with acute coronary syndrome (ACS) treated with coronary artery bypass surgery (CABG). Follow up time is 12-36 months postoperatively and the patency will be evaluated with coronary computed tomography angiography (CCTA)

Trial Health

60
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
360

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Longer than P75 for all trials

Geographic Reach
2 countries

6 active sites

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

First Submitted

Initial submission to the registry

March 2, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 5, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

May 17, 2021

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2026

Completed
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

4.7 years

First QC Date

March 2, 2021

Last Update Submit

December 14, 2025

Conditions

Acute Coronary SyndromeCoronary Bypass Stenosis

Keywords

Acute coronary syndromeCoronary bypass surgeryCoronary computed tomography angiographyAntiplatelet therapy

Outcome Measures

Primary Outcomes (1)

  • Graft patency after CABG

    Defined as patency on CCTA (FitzGibbon A) without previous graft failure identified on CCTA and/or invasive coronary angio (ICA) since CABG, intention to treat (ITT) analysis.

    12-36 months

Secondary Outcomes (5)

  • Graft patency after CABG - PP analysis

    12-36 months

  • Graft patency after CABG

    12-36 months

  • Graft patency after CABG

    12-36 months

  • Graft patency after CABG

    12-36 months

  • Graft patency after CABG

    12-36 months

Other Outcomes (2)

  • Subgroup analyses

    12-36 months

  • Explorative analyses

    12-36 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study will include patients previously included in the TACSI-trial (Dual antiplatelet therapy with ticagrelor and ASA vs. ASA alone after coronary artery bypass grafting in patients with acute coronary syndrome) . This means patients with age ≥18 years that has undergone for the first time an isolated CABG due to an episode of an acute coronary syndrome (ACS) event within 6 weeks before CABG. The randomized, controlled trial TACSI (ClinicalTrials.gov NCT03560310) offers a unique possibility to address the issue of graft patency based on antiplatelet strategy in patients with acute coronary syndromes.

You may qualify if:

  • Previously included in TACSI-trial

You may not qualify if:

  • Highly irregular heart rhythm (i.e. atrial fibrillation)
  • Chronic kidney disease with estimated glomerular filtration rate (eGFR) \<45ml/min/1,73m2
  • Body weight \>120 kg
  • Previous severe allergic reaction (i.e. anaphylactic reaction) to iodine-based contrast agents
  • Not able to communicate
  • Not willing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Department of Heart Disease, Haukeland University Hospital

Bergen, Norway

ENROLLING BY INVITATION

St Olavs University Hospital

Trondheim, Norway

NOT YET RECRUITING

Department of Molecular and Clinical Medicine, Wallenberg Laboratory, Institute of Medicine

Gothenburg, Sweden

ENROLLING BY INVITATION

Dep of Vascular and Thoracic Surgery

Örebro, Sweden

ACTIVE NOT RECRUITING

Department of Cardiothoracic Surgery Karolinska University Hospital

Stockholm, Sweden

ENROLLING BY INVITATION

University Hospital Linköping

Linköping, Östergötland County, 58185, Sweden

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Central Study Contacts

Jonas Holm, MD, PhD

CONTACT

+46101034498jonas.holm@regionostergotland.se

Sofia Sederholm Lawesson, MD, PhD

CONTACT

+461037472sofia.sederholm.lawesson@regionostergotland.se

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 2, 2021

First Posted

March 5, 2021

Study Start

May 17, 2021

Primary Completion

February 1, 2026

Study Completion

March 15, 2026

Last Updated

December 19, 2025

Record last verified: 2025-12

Locations

NO(2)SE(4)