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NCT Number: NCT04783701

Coronary CT Angio Evaluating Graft Patency in ACS Patients Treated With DAPT or Single ASA After CABG (CoCAP)

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)

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Coronary Bypass Stenosis Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Heart Disease, Haukeland University Hospital, Bergen, Norway

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Previously included in TACSI-trial

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Graft patency after CABG

    Time frame: 12-36 months

    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.

Secondary outcomes

  1. Graft patency after CABG - PP analysis

    Time frame: 12-36 months

    Defined as patency on CCTA (FitzGibbon A) without previous graft failure identified on CCTA and/or ICA since CABG, per protocol (PP) analysis.

  2. Graft patency after CABG

    Time frame: 12-36 months

    Defined as non-occlusion on CCTA (FitzGibbon A+B) without previous graft occlusion identified on CCTA and/or ICA since CABG, ITT analysis.

  3. Graft patency after CABG

    Time frame: 12-36 months

    Defined as non-occlusion on CCTA (FitzGibbon A+B) without previous graft occlusion identified on CCTA and/or ICA since CABG, PP analysis.

  4. Graft patency after CABG

    Time frame: 12-36 months

    Defined as patency on CCTA (FitzGibbon A) without graft failure identified on CCTA and/or ICA since CABG, patients on oral anticoagulants excluded, ITT (sensitivity analysis).

  5. Graft patency after CABG

    Time frame: 12-36 months

    Defined as non-occlusion on CCTA (FitzGibbon A) without previous graft failure identified on CCTA and/or ICA since CABG, patients on oral anticoagulants excluded, PP (sensitivity analysis).

Other outcomes

  1. Subgroup analyses

    Time frame: 12-36 months

    Possible interactions in response to study treatment, with special focus on the following factors; age, gender, renal function, diabetes, oral anticoagulant therapy, adherence to study treatment and time from end of study medication.

  2. Explorative analyses

    Time frame: 12-36 months

    Performed on the graft patency of internal mammary artery (IMA) in the two treatment groups, as well as if there are any differences in graft patency between different anastomoses and grafting techniques.

    Possible predictors of graft failure in general, with age, gender, diabetes, obesity, renal failure, urgency level and length of surgery, per-operative complications, number and type of graft as well as pre-operative fractional flow reserve as variables to explore.

    Gender analysis will be performed, analyzing if female gender is associated with worse prognosis post CABG, adjusting for their higher age and burden of co-morbidities.

Study contacts

Contact information is provided by the study sponsor or research team.

Jonas Holm, MD, PhD

CONTACT

[email protected]

+46101034498

Sofia Sederholm Lawesson, MD, PhD

CONTACT

[email protected]

+461037472

Sponsors and collaborators

Lead sponsor

University Hospital, Linkoeping

Other

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Mar 5, 2021
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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