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
- Conditions
- Ticagrelor Compared with Aspirin for Prevention of Vascular Events in Patients Undergoing Coronary Artery Bypass Graft OperationMedDRA version: 19.0Level: LLTClassification code 10003601Term: AtherosclerosisSystem Organ Class: 100000004866Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2012-003630-16-AT
- Lead Sponsor
- German Heart Centre Munich, Department of
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 3850
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
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 noncompliance
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<br>Ticagrelor is superior to Aspirin (ASA) for the prevention of major<br>cardiovascular and cerebrovascular events (MACCE; cardiovascular<br>death, myocardial infarction, recurrent revascularization or stroke) in<br>patients undergoing coronary artery bypass graft operation (CABG).<br>The primary efficacy MACCE-endpoint is the composite of cardiovascular<br>death, myocardial infarction, recurrent revascularization, and stroke at<br>twelve month after coronary artery bypass operation.;Secondary Objective: Not applicable;Primary end point(s): Composite of cardiovascular death, myocardial infarction, recurrent<br>revascularization, and stroke at 12 months after coronary artery bypass<br>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<br>coronary artery bypass operation (Class 4 or 5 periprocedurally<br>respectively Class 3-5 after discharge as defined by the Bleeding<br>Academic Research Consortium, see Appendix 1.).<br>2. Incidence of the individual components of the primary endpoint at 12<br>months after coronary artery bypass operation (cardiovascular death,<br>myocardial infarction, recurrent revascularization, and stroke);Timepoint(s) of evaluation of this end point: 12 months