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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Deutsches Herzzentrum Muenchen
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT01755520
First received: December 19, 2012
Last updated: June 23, 2016
Last verified: June 2016
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Stable Angina
Acute Coronary Syndrome
Drug: Ticagrelor
Drug: Aspirin
Drug: Placebo - Ticagrelor
Drug: Placebo - Aspirin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Parallel Group, Double-Blind Study of Ticagrelor Compared With Aspirin for Prevention of Vascular Events in Patients Undergoing Coronary Artery Bypass Graft Operation TiCAB- Ticagrelor in CABG

Resource links provided by NLM:


Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • MACCE [ Time Frame: at 12 months after coronary artery bypass surgery ] [ Designated as safety issue: No ]
    Composite of cardiovascular death, myocardial infarction, target vessel revascularization, and stroke


Secondary Outcome Measures:
  • Cardiovascular death [ Time Frame: at 12 months after coronary artery bypass surgery ] [ Designated as safety issue: No ]
  • Major bleeding events [ Time Frame: within 12 months after coronary arerty bypass surgery ] [ Designated as safety issue: Yes ]
    Incidence of major bleeding events

  • All cause death [ Time Frame: at 12 months after coronary artery bypass surgery ] [ Designated as safety issue: No ]
    All cause death

  • Myocardial Infarction [ Time Frame: at 12 months after coronary artery bypass surgery ] [ Designated as safety issue: No ]
  • Target Lesion Revascularization [ Time Frame: at 12 months after coronary artery bypass surgery ] [ Designated as safety issue: No ]
  • Stroke [ Time Frame: at 12 months after coronary artery bypass surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 3850
Study Start Date: April 2013
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ticagrelor
Intervention: Drug: Ticagrelor verum + Aspirin placebo
Drug: Ticagrelor
90mg twice daily dose
Other Name: Brilique
Drug: Placebo - Aspirin
Placebo
Other Name: Placebo
Active Comparator: Aspirin
Intervention: Drug: Aspirin verum + Ticagrelor placebo
Drug: Aspirin
Aspirin 100mg once daily
Other Name: ASS
Drug: Placebo - Ticagrelor
Placebo
Other Name: Placebo

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01755520

Contacts
Contact: Heribert Schunkert, MD 00498912184073 schunkert@dhm.mhn.de
Contact: ISAResearch Center 00498912181529 dobler@dhm.mhn.de

Locations
Austria
Medizinische Universität Wien Recruiting
Vienna, Austria, 1090
Contact: Sigrid Sandner, MD    +43-140400 ext 6969    sigrid.sandner@meduniwien.ac.at   
Principal Investigator: Sigird Sandner, MD         
Klinikum Wels-Grieskirchen Completed
Wels, Austria, 4600
Germany
Deutsches Herzzentrum München Recruiting
Munich, Bavaria, Germany, 80636
Contact: Heribert Schunkert, MD    00498912184073    schunkert@dhm.mhn.de   
Contact: Adnan Kastrati, MD    00498912184578    kastrati@dhm.mhn.de   
Principal Investigator: Heribert Schunkert, MD         
Herzzentrum Brandenburg in Bernau Recruiting
Bernau bei Berlin, Brandenburg, Germany, 16321
Contact: Johannes Albes, MD    +493338694510    j.albes@immanuel.de   
Contact: Frank Küpper, MD    +493338694510    f.kuepper@immanuel.de   
Herz- und Kreislaufzentrum Rothenburg an der Fulda Recruiting
Rothenburg an der Fulda, Hesse, Germany, 36199
Contact: Ardawan Julian Rastan, MD    +496623 88-5858    a.rastan@hkz-rotenburg.de   
Principal Investigator: Ardawan Julian Rastan, MD         
Universitätsklinikum Jena Recruiting
Jena, Thuringia, Germany, 07747
Contact: Tim Sandhaus, MD    +4936419322969    tim.sandhaus@med.uni-jena.de   
Principal Investigator: Tim Sandhaus, MD         
Universitätsklinikum Aachen Recruiting
Aachen, Germany, 52074
Contact: Rüdiger Autschbach, MD    +49-241-80 ext 89221    rautschbach@ukaachen.de   
Principal Investigator: Rüdiger Autschbach, MD         
Herz- und Gefäßzentrum Recruiting
Bad Bevensen, Germany, 29549
Contact: Gerhard Wimmer-Greinecker, MD    05821 82-1772    g.wimmer-greinecker@hgz-bb.de   
Principal Investigator: Gerhard Wimmer-Greinecker, MD         
Kerckhoff-Klinik GmbH Recruiting
Bad Nauheim, Germany, 61231
Contact: Thomas Walther, MD    06032/996-2502    t.walther@kerckhoff-klinik.de   
Contact: Tibor Ziegelhöffer, MD    06032/996-2502    t.ziegelhoeffer@kerckhoff-klinik.de   
Principal Investigator: Thomas Walther, MD         
Charité Universitätsmedizin Berlin Recruiting
Berlin, Germany, 10117
Contact: Herko Grubitzsch, MD    +4930450522053    herko.grubitzsch@charite.de   
Principal Investigator: Herko Grubitzsch, MD         
Deutsches Herzzentrum Berlin Recruiting
Berlin, Germany, 13353
Contact: Christoph Knossalla, MD    030 4593-2000    knosalla@dhzb.de   
Principal Investigator: Christoph Knossalla, MD         
Gesundheit Nord gGmbH, Klinikum Links der Weser gGmbH Recruiting
Bremen, Germany, 28277
Contact: Rainer Hambrecht, MD    +49-421-879 ext 1430    rainer.hambrecht@klinikum-bremen-LdW.de   
Principal Investigator: Rainer Hambrecht, MD         
Sana Herzzentrum Cottbus GmbH Recruiting
Cottbus, Germany, 03048
Contact: Jürgen Krülls-Münch, MD    +49-355-46 ext 2576    1.med.klinik@ctk.de   
Principal Investigator: Jürgen Krülls-Münch, MD         
Universitätsklinikum Düsseldorf Active, not recruiting
Düsseldorf, Germany, 40225
Universitätsklinikum Erlangen Recruiting
Erlangen, Germany, 91054
Contact: Christian Schlundt, MD    +49-9131-853 ext 5000    christian.schlundt@uk-erlangen.de   
Principal Investigator: Christian Schlundt, MD         
St. Antonius Hospital Completed
Eschweiler, Germany, 52249
Universitäts-Herzzentrum Freiburg / Bad Krozingen Recruiting
Freiburg, Germany, 79106
Contact: Matthias Siepe, MD    +49-761-2702 ext 4010    matthias.siepe@universitaets-herzzentrum.de   
Principal Investigator: Matthias Siepe, MD         
Universitätsklinikum Gießen Recruiting
Gießen, Germany, 35392
Contact: Andreas Böning, MD    +49-641-985 ext 44300    andreas.boening@chiru.med.uni-giessen.de   
Principal Investigator: Andreas Böning, MD         
Universitätsmedizin Göttingen Recruiting
Göttingen, Germany, 37075
Contact: Bernd Danner, MD    +49-551-39 ext 6061    bernd.danner@med.uni-goettingen.de   
Principal Investigator: Bernd Danner, MD         
Asklepios Klinik St.Georg Recruiting
Hamburg, Germany, 20099
Contact: Martin Oberhoffer, MD    040 18 18 85 4150    m.oberhoffer@asklepios.com   
Principal Investigator: Martin Oberhoffer, MD         
Universitäres Herzzentrum Hamburg GmbH Recruiting
Hamburg, Germany, 20299
Contact: Lenard Conradi, MD    +494074100    lconradi@uke.de   
Principal Investigator: Lenard Conradi, MD         
Universitätsklinikum Schleswig-Holstein, Campus Kiel Recruiting
Kiel, Germany, 24105
Contact: Tim Attmann, MD    +49-431-597 ext 4465    tim.attmann@uksh-kiel.de   
Principal Investigator: Tim Attmann, MD         
Herzzentrum Leipzig GmbH Recruiting
Leipzig, Germany, 04289
Contact: Martin Misfeld, MD    0341 865-1424    martin.misfeld@herzzentrum-leipzig.de   
Principal Investigator: Martin Misfeld, MD         
Klinikum Ludwigshafen Recruiting
Ludwigshafen, Germany, 67063
Contact: Uwe Zeymer, MD    +49-621-503 ext 2941    zeymeru@klilu.de   
Principal Investigator: Uwe Zeymer, MD         
Universitätsklinikum Schleswig-Holstein, Campus Lübeck Recruiting
Lübeck, Germany, 23538
Contact: Alexander Joost, MD    +49-451-5006875    alexander.joost@uksh.de   
Principal Investigator: Alexander Joost, MD         
Kliniken Maria Hilf GmbH Completed
Mönchengladbach, Germany, 41063
Klinikum Nürnberg Süd Recruiting
Nürnberg, Germany, 90419
Contact: Theodor Fischlein, MD    0911 398-5441    theodor.fischlein@klinikum-nuernberg.de   
Principal Investigator: Theodor Fischlein, MD         
Herz- und Kreislaufzentrum Rotenburg a .d. Fulda Recruiting
Rotenburg a .d. Fulda, Germany, 36199
Contact: Ardawan Rastan, MD    06623 885859    a.rastan@hkz-rotenburg.de   
Principal Investigator: Ardawan Rastan, MD         
Krankenhaus der Barmherzigen Brüder Trier Recruiting
Trier, Germany, 54292
Contact: Ivar Friedrich, MD    +49-651-208 ext 2751    i.friedrich@bk-trier.de   
Principal Investigator: Ivar Friedrich, MD         
Switzerland
Schweizer Herz- und Gefässchirurgie Recruiting
Bern, Switzerland, 3010
Contact: Lars Englberger, MD    +41316320    lars.englberger@insel.ch   
Principal Investigator: Lars Englberger, MD         
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
AstraZeneca
Investigators
Study Chair: Heribert Schunkert, MD Deutsches Herzzentrum Munich Germany
  More Information

Responsible Party: Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT01755520     History of Changes
Other Study ID Numbers: GE IDE No. D00112  2012-003630-16 
Study First Received: December 19, 2012
Last Updated: June 23, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Deutsches Herzzentrum Muenchen:
CABG
CAD
antiplatelet drug
Ticagrelor
Aspirin

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Acute Coronary Syndrome
Angina, Stable
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Aspirin
Ticagrelor
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on December 08, 2016