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

Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04783701
• Other study ID #: CoCAP
• Status: Enrolling by invitation
• Start date: May 17, 2021
• Est. completion date: October 1, 2025

Study information

• Verified date: January 2023
• Source: University Hospital, Linkoeping
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 360
• Est. completion date: October 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Bypass Stenosis

Locations

Country	Name	City	State
Norway	Department of Heart Disease, Haukeland University Hospital	Bergen
Norway	St Olavs University Hospital	Trondheim
Sweden	Department of Molecular and Clinical Medicine, Wallenberg Laboratory, Institute of Medicine	Gothenburg
Sweden	University Hospital Linköping	Linköping	Östergötland
Sweden	Department of Cardiothoracic Surgery Karolinska University Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Linkoeping	Forum Östergötland, clinical trial support

Countries where clinical trial is conducted

Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subgroup analyses	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.	12-36 months
Other	Explorative analyses	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.	12-36 months
Primary	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	Graft patency after CABG - PP analysis	Defined as patency on CCTA (FitzGibbon A) without previous graft failure identified on CCTA and/or ICA since CABG, per protocol (PP) analysis.	12-36 months
Secondary	Graft patency after CABG	Defined as non-occlusion on CCTA (FitzGibbon A+B) without previous graft occlusion identified on CCTA and/or ICA since CABG, ITT analysis.	12-36 months
Secondary	Graft patency after CABG	Defined as non-occlusion on CCTA (FitzGibbon A+B) without previous graft occlusion identified on CCTA and/or ICA since CABG, PP analysis.	12-36 months
Secondary	Graft patency after CABG	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).	12-36 months
Secondary	Graft patency after CABG	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).	12-36 months