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)

Study Overview

• Status: Recruiting
• Conditions: Acute Coronary Syndrome; Coronary Bypass Stenosis

• Study Type: Observational
• Enrollment (Estimated): 360

Contacts and Locations

• Study Contact: Name: Jonas Holm, MD, PhD; Phone Number: +46101034498; Email: jonas.holm@regionostergotland.se
• Study Contact Backup: Name: Sofia Sederholm Lawesson, MD, PhD; Phone Number: +461037472; Email: sofia.sederholm.lawesson@regionostergotland.se

Study Locations

• Norway
  • Bergen, Norway
    • Enrolling by invitation
    • Department of Heart Disease, Haukeland University Hospital
  • Trondheim, Norway
    • Not yet recruiting
    • St Olavs University Hospital
    • Contact: Alexander Wahba, MD, Prof; Email: alexander.wahba@ntnu.no
• Sweden
  • Gothenburg, Sweden
    • Enrolling by invitation
    • Department of Molecular and Clinical Medicine, Wallenberg Laboratory, Institute of Medicine
  • Stockholm, Sweden
    • Enrolling by invitation
    • Department of Cardiothoracic Surgery Karolinska University Hospital
  • Örebro, Sweden
    • Active, not recruiting
    • Dep of Vascular and Thoracic Surgery
  • Östergötland County
    • Linköping, Östergötland County, Sweden, 58185
      • Recruiting
      • University Hospital Linköping
      • Contact: Jonas Holm, MD,PhD; Phone Number: +46101034498; Email: jonas.holm@regionostergotland.se
      • Contact: Sofia Sederholm Lawesson, MD,PhD; Phone Number: +46101037472; Email: sofia.sederholm.lawesson@regionostergotland.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Linkoeping
• Collaborators: Forum Östergötland, clinical trial support

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2021
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): March 15, 2026

Study Registration Dates

• First Submitted: March 2, 2021
• First Submitted That Met QC Criteria: March 2, 2021
• First Posted (Actual): March 5, 2021

Study Record Updates

• Last Update Posted (Estimated): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 14, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Acute coronary syndrome; Antiplatelet therapy; Coronary computed tomography angiography; Coronary bypass surgery
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Myocardial Ischemia; Acute Coronary Syndrome
• Other Study ID Numbers: CoCAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No