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

Sponsor
Deutsches Herzzentrum Muenchen (Other)
Overall Status
Terminated
CT.gov ID
NCT01755520
Collaborator
AstraZeneca (Industry)
1,893
Enrollment
29
Locations
2
Arms
60.8
Duration (Months)
65.3
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
1893 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, 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
Study Start Date :
Apr 24, 2013
Actual Primary Completion Date :
May 19, 2018
Actual Study Completion Date :
May 19, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ticagrelor

Intervention: Drug: Ticagrelor verum + Aspirin placebo

Drug: Ticagrelor
90mg twice daily dose
Other Names:
  • Brilique

    • Drug: Placebo - Aspirin
    Placebo
    Other Names:
  • Placebo

    		•
    Active Comparator: Aspirin

    Intervention: Drug: Aspirin verum + Ticagrelor placebo

    Drug: Aspirin
    Aspirin 100mg once daily
    Other Names:
  • ASS

    • Drug: Placebo - Ticagrelor
    Placebo
    Other Names:
  • Placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. MACCE [at 12 months after coronary artery bypass surgery]

      Composite of cardiovascular death, myocardial infarction, target vessel revascularization, and stroke

    Secondary Outcome Measures

    1. Cardiovascular death [at 12 months after coronary artery bypass surgery]

    2. Major bleeding events [within 12 months after coronary arerty bypass surgery]

      Incidence of major bleeding events

    3. All cause death [at 12 months after coronary artery bypass surgery]

      All cause death

    4. Myocardial Infarction [at 12 months after coronary artery bypass surgery]

    5. Target Lesion Revascularization [at 12 months after coronary artery bypass surgery]

    6. Stroke [at 12 months after coronary artery bypass surgery]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

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

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

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medizinische Universität Wien Vienna Austria 1090
    2 Klinikum Wels-Grieskirchen Wels Austria 4600
    3 Deutsches Herzzentrum München Munich Bavaria Germany 80636
    4 Herzzentrum Brandenburg in Bernau Bernau bei Berlin Brandenburg Germany 16321
    5 Herz- und Kreislaufzentrum Rothenburg an der Fulda Rotenburg An Der Fulda Hesse Germany 36199
    6 Universitätsklinikum Jena Jena Thuringia Germany 07747
    7 Universitätsklinikum Aachen Aachen Germany 52074
    8 Herz- und Gefäßzentrum Bad Bevensen Germany 29549
    9 Kerckhoff-Klinik GmbH Bad Nauheim Germany 61231
    10 Charité Universitätsmedizin Berlin Berlin Germany 10117
    11 Deutsches Herzzentrum Berlin Berlin Germany 13353
    12 Gesundheit Nord gGmbH, Klinikum Links der Weser gGmbH Bremen Germany 28277
    13 Sana Herzzentrum Cottbus GmbH Cottbus Germany 03048
    14 Universitätsklinikum Düsseldorf Düsseldorf Germany 40225
    15 Universitätsklinikum Erlangen Erlangen Germany 91054
    16 St. Antonius Hospital Eschweiler Germany 52249
    17 Universitäts-Herzzentrum Freiburg / Bad Krozingen Freiburg Germany 79106
    18 Universitätsklinikum Gießen Gießen Germany 35392
    19 Universitätsmedizin Göttingen Göttingen Germany 37075
    20 Asklepios Klinik St.Georg Hamburg Germany 20099
    21 Universitäres Herzzentrum Hamburg GmbH Hamburg Germany 20299
    22 Universitätsklinikum Schleswig-Holstein, Campus Kiel Kiel Germany 24105
    23 Herzzentrum Leipzig GmbH Leipzig Germany 04289
    24 Klinikum Ludwigshafen Ludwigshafen Germany 67063
    25 Universitätsklinikum Schleswig-Holstein, Campus Lübeck Lübeck Germany 23538
    26 Kliniken Maria Hilf GmbH Mönchengladbach Germany 41063
    27 Klinikum Nürnberg Süd Nürnberg Germany 90419
    28 Krankenhaus der Barmherzigen Brüder Trier Trier Germany 54292
    29 Schweizer Herz- und Gefässchirurgie Bern Switzerland 3010

    Sponsors and Collaborators

    • Deutsches Herzzentrum Muenchen
    • AstraZeneca

    Investigators

    • Study Chair: Heribert Schunkert, MD, Deutsches Herzzentrum Munich Germany

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Deutsches Herzzentrum Muenchen
    ClinicalTrials.gov Identifier:
    NCT01755520
    Other Study ID Numbers:
    • GE IDE No. D00112
    • 2012-003630-16
    First Posted:
    Dec 24, 2012
    Last Update Posted:
    Aug 2, 2018
    Last Verified:
    Aug 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Deutsches Herzzentrum Muenchen
    CABG
    CAD
    antiplatelet drug
    Ticagrelor
    Aspirin
    Additional relevant MeSH terms:
    Coronary Artery Disease
    Acute Coronary Syndrome
    Angina, Stable
    Aspirin
    Ticagrelor

    Study Results

    No Results Posted as of Aug 2, 2018