Clinical trial NCT04783701: Coronary CT Angio Evaluating Graft Patency in ACS Patients Treated With DAPT or Single ASA After CABG (CoCAP)
Official title: Coronary CT Angio Evaluating Graft Patency in ACS Patients Treated With DAPT or Single ASA After CABG (CoCAP)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Acute Coronary Syndrome
Coronary Bypass Stenosis
Keywords: Acute coronary syndrome
Coronary bypass surgery
Coronary computed tomography angiography
Antiplatelet therapy
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
Collaborators: name: Forum Östergötland, clinical trial support
First posted: 2021-03-05
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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)


Eligibility criteria: 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

Primary outcomes:
measure: Graft patency after CABG
timeFrame: 12-36 months
Secondary outcomes:
measure: Graft patency after CABG - PP analysis
timeFrame: 12-36 months
measure: Graft patency after CABG
timeFrame: 12-36 months
measure: Graft patency after CABG
timeFrame: 12-36 months
measure: Graft patency after CABG
timeFrame: 12-36 months
measure: Graft patency after CABG
timeFrame: 12-36 months
Other outcomes:
measure: Subgroup analyses
timeFrame: 12-36 months
measure: Explorative analyses
timeFrame: 12-36 months
Locations:
city: Bergen
country: Norway
facility: Department of Heart Disease, Haukeland University Hospital
city: Trondheim
country: Norway
facility: St Olavs University Hospital
city: Gothenburg
country: Sweden
facility: Department of Molecular and Clinical Medicine, Wallenberg Laboratory, Institute of Medicine
city: Stockholm
country: Sweden
facility: Department of Cardiothoracic Surgery Karolinska University Hospital
city: Linköping
country: Sweden
facility: University Hospital Linköping
state: Östergötland
Study officials:
References: