Study Comparing Ticagrelor With Aspirin for Prevention of Vascular Events in Patients Undergoing CABG

• Status: Terminated
• Trial end date: 2018-05-19
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study ist to test the hypothesis that ticagrelor is superior to Aspirin (ASA) fort he prevention of major cardio- and cerebrovascular events (MACCE) in patients undergoing artery bypass operation.

The primary efficiacy MACCE-endpoint is the composite of cardiovascular death, myocardial infarction, recurent revascularisation, and stroke at twelve month after coronary artery bypass operation.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Deutsches Herzzentrum Muenchen
• Collaborator: AstraZeneca
• Treatments: Aspirin; Ticagrelor

Criteria

Inclusion Criteria:

1. Patients 18 years of age or older

2. Informed, written consent by the patient

3. Indication for CABG surgery:

• coronary three vessel disease, or

• left main stenosis, or

• two vessel disease with impaired left ventricular function (<50%)

Exclusion Criteria:

1. Cardiogenic shock, haemodynamic instability

2. Indication for oral anticoagulation or dual antiplatelet therapy that can not be stopped after CABG

3. Need for concomitant non-coronary surgery (e.g. valve replacement)

4. Intolerance of or Allergy to Ticagrelor or ASA or any of their ingredients

5. History of bleeding diathesis within three months prior presentation

6. History of significant gastrointestinal bleeding within six months prior presentation

7. History of intracranial hemorrhage

8. History of moderate to severe liver impairment (Child Pugh B or C)

9. Chronic renal insufficiency requiring dialysis

10. Patient with an increased risk of bradycardic events (e.g. patients without a pacemaker who have sick sinus syndrome, 2nd or 3rd degree AV block or bradycardic-related syncope)

11. Known, clinically important thrombocytopenia (i.e. <100.000/µl)

12. Known, clinically important anaemia (i.e. <10mg/dl)

13. Participation in another investigational drug or device study in the last 30 days

14. Pregnancy or lactation (for premenopausal women 2 methods of reliable contraception, one of which must be barrier method, are required); in women with childbearing potential a pregnancy test is mandatory

15. Concomitant oral or intravenous therapy (see examples below) with strong CYP3A inhibitors, CYP3A substrates with narrow therapeutic indices, or strong CYP3A inducers which cannot be stopped for the course of the study

• Strong inhibitors: ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, over 1 litre daily of grapefruit juice.

• Substrates with narrow therapeutic index: cyclosporine, quinidine.

• Strong inducers: rifampin/rifampicin, phenytoin, carbamazepine.

16. Life expectancy less than 12 months that may result in protocol non-compliance or a risk for being lost to follow-up, active cancer

17. Indication for major surgery (e.g. cancer treatment, carotid surgery, cerebral surgery, major vascular surgery)

18. Previous enrollment or randomization of treatment in the present study.