Ireland
--:--IST
Active, not recruiting Phase 4

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

NCT03560310 · tracked via the Priya Life Science Sweden tracker
Phase
Phase 4
Started
2018-06-29
Last updated
2025-09-02

Condition(s) studied

Acute Coronary Syndrome

Investigational drug(s) / intervention(s)

Ticagrelor 90mg twice daily and ASA 75-100 mg dailyASA 75-160 mg daily

Ticagrelor 90mg twice daily and ASA 75-100 mg daily: Assess whether ticagrelor 90 mg twice daily and ASA 75-100 mg daily versus ASA 75-160 mg daily improves outcome after isolated coronary artery bypass grafting in patients with acute coronary syndrome

ASA 75-160 mg daily: Assess whether ticagrelor 90 mg twice daily and ASA 75-100 mg daily versus ASA 75-160 mg daily improves outcome after isolated coronary artery bypass grafting in patients with acute coronary syndrome

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Time to major adverse cardiovascular events (MACE) — within12 months
    To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone improves 12 months outcome defined as time to major adverse cardiovascular events (MACE) after isolated CABG in ACS patients. MACE includes all-cause mortality, myocardial infarction, stroke and new revascularization.

Trial sites (22)

FacilityCityRegionStatus
Aalborg University Hospital Aalborg Denmark
Aarhus University Hospital Aarhus Denmark
Rigshospitalet Copenhagen Denmark
Odense University Hospital Odense Denmark
Helsinki University Hospital Helsinki Finland
Kuopio University Hospital Kuopio Finland
Oulu University Hospital Oulu Finland
Tampere University Hospital Tampere Finland
Turku University Hospital Turku Finland
Landspítali University Hospital Reykjavik Iceland
St. Olavs hospital, University Hospital Bergen Norway
Oslo University Hospital Oslo Norway
University Hospital of North Norway Tromsø Norway
Haukeland University Hospital Trondheim Norway
Sahlgrenska University Hospital Gothenburg Sweden
Blekinge Hospital Karlskrona Sweden
Linköping University Hospital Linköping Sweden
Skåne University Hospital Lund Sweden
Örebro University Hospital Örebro Sweden
Karolinska University Hospital Stockholm Sweden
University Hospital of Umeå Umeå Sweden
Uppsala University Hospital Uppsala Sweden
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03560310 on ClinicalTrials.gov ↗ ← All trials in Sweden