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

• Conditions: Coronary Bypass Stenosis; Acute Coronary Syndrome

• Registration Number: NCT04783701
• Lead Sponsor: University Hospital, Linkoeping

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-02
• Study First Submitted QC: 2021-03-02
• Study First Posted: 2021-03-05
• Study Start: 2021-05-17
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-18
• Last Update Posted: 2023-01-20
• Primary Completion: 2025-05-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 360

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Graft patency after CABG	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 Outcome Measures

Name	Time	Method
Graft patency after CABG	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).
Graft patency after CABG - PP analysis	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.

Trial Locations

Locations (5)

University Hospital Linköping; 🇸🇪 Linköping, Östergötland, Sweden

Department of Molecular and Clinical Medicine, Wallenberg Laboratory, Institute of Medicine; 🇸🇪 Gothenburg, Sweden

Department of Heart Disease, Haukeland University Hospital; 🇳🇴 Bergen, Norway

St Olavs University Hospital; 🇳🇴 Trondheim, Norway

Department of Cardiothoracic Surgery Karolinska University Hospital; 🇸🇪 Stockholm, Sweden