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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01755520
Other study ID # GE IDE No. D00112
Secondary ID 2012-003630-16
Status Terminated
Phase Phase 3
First received
Last updated
Start date April 24, 2013
Est. completion date May 19, 2018

Study information

Verified date August 2018
Source Deutsches Herzzentrum Muenchen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

For stable patients who underwent coronary bypass operation, Aspirin alone currently represents the gold standard of antiplatelet treatment.

The CABG substudy of the PLATO-trial (http://www.nejm.org/doi/full/10.1056/NEJMoa0904327) comprising more than 1200 patients has convincingly shown a high significant reduction of cardiovascular and all-cause mortality for patients recieving Aspirin and Ticagrelor as compared to those subjects randomized to Aspirin plus Clopidogrel. Moreover the results of the PLATO CABG substudy showed that benefits of Ticagrelor increase with decreasing Aspirin doses. Therefore Ticagrelor monotherapy (2x 90mg/day) appears to offer the best balance of safety with anticipated improved efficacy over Aspirin (1x 100mg/day) alone, but until now there are no further data available to support this hypothesis.

Hence this study (TiCAB) is assigned as a pivotal efficacy and safety study of Ticagrelor in patients undergoing coronary artery bypass operation and to test the hypothesis that ticagrelor is superior to Aspirin for the prevention of major cardio- and cerebrovascular events (MACCE) in this patient population.

The TiCAB trial is designed as a randomized, double-blind, double-dummy, parallel group, phase III, multicenter study, comparing the efficacy and safety of Ticagrelor 90mg administered twice daily with Aspirin 100mg once daily, for the prevention of MACCE within the first year after CABG operation.


Recruitment information / eligibility

Status Terminated
Enrollment 1893
Est. completion date May 19, 2018
Est. primary completion date May 19, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Drug:
Ticagrelor
90mg twice daily dose
Aspirin
Aspirin 100mg once daily
Placebo - Ticagrelor
Placebo
Placebo - Aspirin
Placebo

Locations

Country Name City State
Austria Medizinische Universität Wien Vienna
Austria Klinikum Wels-Grieskirchen Wels
Germany Universitätsklinikum Aachen Aachen
Germany Herz- und Gefäßzentrum Bad Bevensen
Germany Kerckhoff-Klinik GmbH Bad Nauheim
Germany Charité Universitätsmedizin Berlin Berlin
Germany Deutsches Herzzentrum Berlin Berlin
Germany Herzzentrum Brandenburg in Bernau Bernau bei Berlin Brandenburg
Germany Gesundheit Nord gGmbH, Klinikum Links der Weser gGmbH Bremen
Germany Sana Herzzentrum Cottbus GmbH Cottbus
Germany Universitätsklinikum Düsseldorf Düsseldorf
Germany Universitätsklinikum Erlangen Erlangen
Germany St. Antonius Hospital Eschweiler
Germany Universitäts-Herzzentrum Freiburg / Bad Krozingen Freiburg
Germany Universitätsklinikum Gießen Gießen
Germany Universitätsmedizin Göttingen Göttingen
Germany Asklepios Klinik St.Georg Hamburg
Germany Universitäres Herzzentrum Hamburg GmbH Hamburg
Germany Universitätsklinikum Jena Jena Thuringia
Germany Universitätsklinikum Schleswig-Holstein, Campus Kiel Kiel
Germany Herzzentrum Leipzig GmbH Leipzig
Germany Universitätsklinikum Schleswig-Holstein, Campus Lübeck Lübeck
Germany Klinikum Ludwigshafen Ludwigshafen
Germany Kliniken Maria Hilf GmbH Mönchengladbach
Germany Deutsches Herzzentrum München Munich Bavaria
Germany Klinikum Nürnberg Süd Nürnberg
Germany Herz- und Kreislaufzentrum Rothenburg an der Fulda Rotenburg An Der Fulda Hesse
Germany Krankenhaus der Barmherzigen Brüder Trier Trier
Switzerland Schweizer Herz- und Gefässchirurgie Bern

Sponsors (2)

Lead Sponsor Collaborator
Deutsches Herzzentrum Muenchen AstraZeneca

Countries where clinical trial is conducted

Austria,  Germany,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary MACCE Composite of cardiovascular death, myocardial infarction, target vessel revascularization, and stroke at 12 months after coronary artery bypass surgery
Secondary Cardiovascular death at 12 months after coronary artery bypass surgery
Secondary Major bleeding events Incidence of major bleeding events within 12 months after coronary arerty bypass surgery
Secondary All cause death All cause death at 12 months after coronary artery bypass surgery
Secondary Myocardial Infarction at 12 months after coronary artery bypass surgery
Secondary Target Lesion Revascularization at 12 months after coronary artery bypass surgery
Secondary Stroke at 12 months after coronary artery bypass surgery
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