Overview

Ticagrelor and ASA vs. ASA Only After Isolated Coronary Artery Bypass Grafting in Patients With Acute Coronary Syndrome

Status:
Recruiting
Trial end date:
2031-06-01
Target enrollment:
0
Participant gender:
All
Summary
The study is a Randomised Registry-based Clinical Trial (RRCT) to assess whether dual antiplatelet therapy with ticagrelor and ASA compared to ASA alone improves outcome after isolated CABG in patients with acute coronary syndrome.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Vastra Gotaland Region
Collaborators:
Gothia Forum
Gothia Forum - Center for Clinical Trial
Uppsala University
Treatments:
Adenosine
Aspirin
Ticagrelor
Criteria
Inclusion Criteria:

1. Written informed consent

2. Age ≥18 years

3. Has undergone first time isolated CABG due to an episode of acute coronary syndrome
(STEMI, NSTEMI, unstable angina) within 6 weeks before surgery

Exclusion Criteria:

1. Previously enrolled in this study (i.e. patient now at repeat encounter)

2. Concomitant surgical procedure other than CABG

3. Anticoagulant treatment after the operation (e.g. warfarin, direct thrombin inhibitors
(dabigatran), FXa inhibitors (rivaroxaban, apixaban, heparin, low-molecular weight
heparin, fondaparinux)

4. Discharge from the operating hospital to an ICU at another hospital

5. Pregnancy or lactation

6. Known intolerance or contraindication to ticagrelor or ASA

7. Any disorder that may interfere with drug absorption

8. Any condition other than coronary artery disease with a life expectancy <12 months

9. Known chronic liver disease, renal disease requiring dialysis or bleeding disorder

10. Atrioventricular block II and III in patients without pacemaker

11. Any other indication for dual antiplatelet therapy, i.e. recent stent implantation

12. Debilitating stroke within 90 days before inclusion

13. Previous intracranial bleeding

14. Treatment with immunosuppressants (e.g. cyclosporine and tacrolimus)

15. Treatment with strong CYP3A4-inhibitors (e.g. ketoconazole, clarithromycin,
nefazodone, ritonavir or atazanavir)

16. Any condition that in the opinion of the investigator may interfere with adherence to
trial protocol

17. Participation in any other clinical trial evaluating investigational products at the
time for enrollment in this study