ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01755520
Recruitment Status : Terminated (DSMB Interim Analyses)
First Posted : December 24, 2012
Last Update Posted : August 2, 2018
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen

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
Coronary Artery Disease Stable Angina Acute Coronary Syndrome Drug: Ticagrelor Drug: Aspirin Drug: Placebo - Ticagrelor Drug: Placebo - Aspirin 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 Type : Interventional  (Clinical Trial)
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 : April 24, 2013
Actual Primary Completion Date : May 19, 2018
Actual Study Completion Date : May 19, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. MACCE [ Time Frame: 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 [ Time Frame: at 12 months after coronary artery bypass surgery ]
  2. Major bleeding events [ Time Frame: within 12 months after coronary arerty bypass surgery ]
    Incidence of major bleeding events

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

  4. Myocardial Infarction [ Time Frame: at 12 months after coronary artery bypass surgery ]
  5. Target Lesion Revascularization [ Time Frame: at 12 months after coronary artery bypass surgery ]
  6. Stroke [ Time Frame: at 12 months after coronary artery bypass surgery ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01755520


Locations
Austria
Medizinische Universität Wien
Vienna, Austria, 1090
Klinikum Wels-Grieskirchen
Wels, Austria, 4600
Germany
Deutsches Herzzentrum München
Munich, Bavaria, Germany, 80636
Herzzentrum Brandenburg in Bernau
Bernau bei Berlin, Brandenburg, Germany, 16321
Herz- und Kreislaufzentrum Rothenburg an der Fulda
Rotenburg An Der Fulda, Hesse, Germany, 36199
Universitätsklinikum Jena
Jena, Thuringia, Germany, 07747
Universitätsklinikum Aachen
Aachen, Germany, 52074
Herz- und Gefäßzentrum
Bad Bevensen, Germany, 29549
Kerckhoff-Klinik GmbH
Bad Nauheim, Germany, 61231
Charité Universitätsmedizin Berlin
Berlin, Germany, 10117
Deutsches Herzzentrum Berlin
Berlin, Germany, 13353
Gesundheit Nord gGmbH, Klinikum Links der Weser gGmbH
Bremen, Germany, 28277
Sana Herzzentrum Cottbus GmbH
Cottbus, Germany, 03048
Universitätsklinikum Düsseldorf
Düsseldorf, Germany, 40225
Universitätsklinikum Erlangen
Erlangen, Germany, 91054
St. Antonius Hospital
Eschweiler, Germany, 52249
Universitäts-Herzzentrum Freiburg / Bad Krozingen
Freiburg, Germany, 79106
Universitätsklinikum Gießen
Gießen, Germany, 35392
Universitätsmedizin Göttingen
Göttingen, Germany, 37075
Asklepios Klinik St.Georg
Hamburg, Germany, 20099
Universitäres Herzzentrum Hamburg GmbH
Hamburg, Germany, 20299
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, Germany, 24105
Herzzentrum Leipzig GmbH
Leipzig, Germany, 04289
Klinikum Ludwigshafen
Ludwigshafen, Germany, 67063
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lübeck, Germany, 23538
Kliniken Maria Hilf GmbH
Mönchengladbach, Germany, 41063
Klinikum Nürnberg Süd
Nürnberg, Germany, 90419
Krankenhaus der Barmherzigen Brüder Trier
Trier, Germany, 54292
Switzerland
Schweizer Herz- und Gefässchirurgie
Bern, Switzerland, 3010
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
AstraZeneca
Investigators
Study Chair: Heribert Schunkert, MD Deutsches Herzzentrum Munich Germany

Responsible Party: Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT01755520     History of Changes
Other Study ID Numbers: GE IDE No. D00112
2012-003630-16 ( EudraCT Number )
First Posted: December 24, 2012    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
Aspirin
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
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