A Randomized, Parallel Group, Double-Blind Study of Ticagrelor Compared with Aspirin for Prevention of Vascular Events in Patients Undergoing Coronary Artery Bypass Graft OperationTiCAB– Ticagrelor in CABG

Phase 1

• Conditions: Ticagrelor Compared with Aspirin for Prevention of Vascular Events in Patients Undergoing Coronary Artery Bypass Graft Operation; MedDRA version: 20.0Level: LLTClassification code 10003601Term: AtherosclerosisSystem Organ Class: 100000004866; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-003630-16-DE
• Lead Sponsor: German Heart Centre Munich, Department of

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-24
• Last Update Posted: 18 June 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 3850

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%)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1925
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1925

Exclusion Criteria

1. Cardiogenic shock, haemodynamic instability
2. Indication for oral anticoagulation or dual antiplatelet therapy that cannot be stopped after CABG
3. Need for concomitant non-coronary surgery (e.g. valve replacement)
4. Contraindication for ASA or Ticagrelor use (e.g. known allergy)
5. Intolerance of or allergy to Ticagrelor or ASA or any of their excipients
6. History of bleeding diathesis within three months prior presentation,
7. History of significant gastrointestinal bleed within 6 months prior presentation
8. History of intracranial hemorrhage
9. History of moderate to severe liver impairment (Child Pugh B or C)
10. Chronic renal insufficiency requiring dialysis
11. 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)
12. Known, clinically important thrombocytopenia (e.g. <100.000/µl)
13. Known, clinically important anaemia (e.g. <10g/dl)
14. Participation in another investigational drug or device study in the last 30 days
15. 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
16. 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
o Strong inhibitors: ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atanazavir, over 1 liter daily of grapefruit juice.
o Substrates with narrow therapeutic index: cyclosporine, quinidine.
o Strong inducers: rifampin/rifampicin, phenytoin, carbamazepine.
17. Life expectancy less than 12 months that may result in protocol non-compliance or a risk for being lost to follow up, active cancer
18. Indication for major surgery (e.g. cancer treatment, carotid surgery, cerebral surgery, major vascular surgery)
19. Previous enrolment or randomization of treatment in the present study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to test the hypothesis that Ticagrelor is superior to Aspirin (ASA) for the prevention of major cardiovascular and cerebrovascular events (MACCE; cardiovascular death, myocardial infarction, recurrent revascularization or stroke) in patients undergoing coronary artery bypass graft operation (CABG).<br>The primary efficacy MACCE-endpoint is the composite of cardiovascular death, myocardial infarction, recurrent revascularization, and stroke at twelve month after coronary artery bypass operation.;Secondary Objective: Not applicable;Primary end point(s): Composite of cardiovascular death, myocardial infarction, recurrent revascularization, and stroke at 12 months after coronary artery bypass operation;Timepoint(s) of evaluation of this end point: 12 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Safety endpoint: The incidence of major bleeding at 12 months after coronary artery bypass operation (Class 4 or 5 periprocedurally respectively Class 3-5 after discharge as defined by the Bleeding Academic Research Consortium, see Appendix 1.).<br>2. Incidence of the individual components of the primary endpoint at 12 months after coronary artery bypass operation (cardiovascular death, myocardial infarction, recurrent revascularization, and stroke);Timepoint(s) of evaluation of this end point: 12 months