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

Primary Purpose

Coronary Artery Disease, Stable Angina, Acute Coronary Syndrome

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ticagrelor
Aspirin
Placebo - Ticagrelor
Placebo - Aspirin
Sponsored by
Deutsches Herzzentrum Muenchen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring CABG, CAD, antiplatelet drug, Ticagrelor, Aspirin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medizinische Universität Wien
  • Klinikum Wels-Grieskirchen
  • Deutsches Herzzentrum München
  • Herzzentrum Brandenburg in Bernau
  • Herz- und Kreislaufzentrum Rothenburg an der Fulda
  • Universitätsklinikum Jena
  • Universitätsklinikum Aachen
  • Herz- und Gefäßzentrum
  • Kerckhoff-Klinik GmbH
  • Charité Universitätsmedizin Berlin
  • Deutsches Herzzentrum Berlin
  • Gesundheit Nord gGmbH, Klinikum Links der Weser gGmbH
  • Sana Herzzentrum Cottbus GmbH
  • Universitätsklinikum Düsseldorf
  • Universitätsklinikum Erlangen
  • St. Antonius Hospital
  • Universitäts-Herzzentrum Freiburg / Bad Krozingen
  • Universitätsklinikum Gießen
  • Universitätsmedizin Göttingen
  • Asklepios Klinik St.Georg
  • Universitäres Herzzentrum Hamburg GmbH
  • Universitätsklinikum Schleswig-Holstein, Campus Kiel
  • Herzzentrum Leipzig GmbH
  • Klinikum Ludwigshafen
  • Universitätsklinikum Schleswig-Holstein, Campus Lübeck
  • Kliniken Maria Hilf GmbH
  • Klinikum Nürnberg Süd
  • Krankenhaus der Barmherzigen Brüder Trier
  • Schweizer Herz- und Gefässchirurgie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ticagrelor

Aspirin

Arm Description

Intervention: Drug: Ticagrelor verum + Aspirin placebo

Intervention: Drug: Aspirin verum + Ticagrelor placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Cardiovascular death
Major bleeding events
Incidence of major bleeding events
All cause death
All cause death
Myocardial Infarction
Target Lesion Revascularization
Stroke

Full Information

First Posted
December 19, 2012
Last Updated
August 1, 2018
Sponsor
Deutsches Herzzentrum Muenchen
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01755520
Brief Title
Study Comparing Ticagrelor With Aspirin for Prevention of Vascular Events in Patients Undergoing CABG
Acronym
TiCAB
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 Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
DSMB Interim Analyses
Study Start Date
April 24, 2013 (undefined)
Primary Completion Date
May 19, 2018 (Actual)
Study Completion Date
May 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Deutsches Herzzentrum Muenchen
Collaborators
AstraZeneca

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Stable Angina, Acute Coronary Syndrome
Keywords
CABG, CAD, antiplatelet drug, Ticagrelor, Aspirin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1893 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ticagrelor
Arm Type
Experimental
Arm Description
Intervention: Drug: Ticagrelor verum + Aspirin placebo
Arm Title
Aspirin
Arm Type
Active Comparator
Arm Description
Intervention: Drug: Aspirin verum + Ticagrelor placebo
Intervention Type
Drug
Intervention Name(s)
Ticagrelor
Other Intervention Name(s)
Brilique
Intervention Description
90mg twice daily dose
Intervention Type
Drug
Intervention Name(s)
Aspirin
Other Intervention Name(s)
ASS
Intervention Description
Aspirin 100mg once daily
Intervention Type
Drug
Intervention Name(s)
Placebo - Ticagrelor
Other Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Placebo - Aspirin
Other Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
MACCE
Description
Composite of cardiovascular death, myocardial infarction, target vessel revascularization, and stroke
Time Frame
at 12 months after coronary artery bypass surgery
Secondary Outcome Measure Information:
Title
Cardiovascular death
Time Frame
at 12 months after coronary artery bypass surgery
Title
Major bleeding events
Description
Incidence of major bleeding events
Time Frame
within 12 months after coronary arerty bypass surgery
Title
All cause death
Description
All cause death
Time Frame
at 12 months after coronary artery bypass surgery
Title
Myocardial Infarction
Time Frame
at 12 months after coronary artery bypass surgery
Title
Target Lesion Revascularization
Time Frame
at 12 months after coronary artery bypass surgery
Title
Stroke
Time Frame
at 12 months after coronary artery bypass surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients 18 years of age or older Informed, written consent by the patient Indication for CABG surgery: coronary three vessel disease, or left main stenosis, or two vessel disease with impaired left ventricular function (<50%) Exclusion Criteria: Cardiogenic shock, haemodynamic instability Indication for oral anticoagulation or dual antiplatelet therapy that can not be stopped after CABG Need for concomitant non-coronary surgery (e.g. valve replacement) Intolerance of or Allergy to Ticagrelor or ASA or any of their ingredients History of bleeding diathesis within three months prior presentation History of significant gastrointestinal bleeding within six months prior presentation History of intracranial hemorrhage History of moderate to severe liver impairment (Child Pugh B or C) Chronic renal insufficiency requiring dialysis 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) Known, clinically important thrombocytopenia (i.e. <100.000/µl) Known, clinically important anaemia (i.e. <10mg/dl) Participation in another investigational drug or device study in the last 30 days 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 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. Life expectancy less than 12 months that may result in protocol non-compliance or a risk for being lost to follow-up, active cancer Indication for major surgery (e.g. cancer treatment, carotid surgery, cerebral surgery, major vascular surgery) Previous enrollment or randomization of treatment in the present study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heribert Schunkert, MD
Organizational Affiliation
Deutsches Herzzentrum Munich Germany
Official's Role
Study Chair
Facility Information:
Facility Name
Medizinische Universität Wien
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Klinikum Wels-Grieskirchen
City
Wels
ZIP/Postal Code
4600
Country
Austria
Facility Name
Deutsches Herzzentrum München
City
Munich
State/Province
Bavaria
ZIP/Postal Code
80636
Country
Germany
Facility Name
Herzzentrum Brandenburg in Bernau
City
Bernau bei Berlin
State/Province
Brandenburg
ZIP/Postal Code
16321
Country
Germany
Facility Name
Herz- und Kreislaufzentrum Rothenburg an der Fulda
City
Rotenburg An Der Fulda
State/Province
Hesse
ZIP/Postal Code
36199
Country
Germany
Facility Name
Universitätsklinikum Jena
City
Jena
State/Province
Thuringia
ZIP/Postal Code
07747
Country
Germany
Facility Name
Universitätsklinikum Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Herz- und Gefäßzentrum
City
Bad Bevensen
ZIP/Postal Code
29549
Country
Germany
Facility Name
Kerckhoff-Klinik GmbH
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
Charité Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Deutsches Herzzentrum Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Gesundheit Nord gGmbH, Klinikum Links der Weser gGmbH
City
Bremen
ZIP/Postal Code
28277
Country
Germany
Facility Name
Sana Herzzentrum Cottbus GmbH
City
Cottbus
ZIP/Postal Code
03048
Country
Germany
Facility Name
Universitätsklinikum Düsseldorf
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
St. Antonius Hospital
City
Eschweiler
ZIP/Postal Code
52249
Country
Germany
Facility Name
Universitäts-Herzzentrum Freiburg / Bad Krozingen
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Universitätsklinikum Gießen
City
Gießen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Universitätsmedizin Göttingen
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Asklepios Klinik St.Georg
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
Universitäres Herzzentrum Hamburg GmbH
City
Hamburg
ZIP/Postal Code
20299
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein, Campus Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Herzzentrum Leipzig GmbH
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Facility Name
Klinikum Ludwigshafen
City
Ludwigshafen
ZIP/Postal Code
67063
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Kliniken Maria Hilf GmbH
City
Mönchengladbach
ZIP/Postal Code
41063
Country
Germany
Facility Name
Klinikum Nürnberg Süd
City
Nürnberg
ZIP/Postal Code
90419
Country
Germany
Facility Name
Krankenhaus der Barmherzigen Brüder Trier
City
Trier
ZIP/Postal Code
54292
Country
Germany
Facility Name
Schweizer Herz- und Gefässchirurgie
City
Bern
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31750899
Citation
Sandner SE, Schunkert H, Kastrati A, Wiedemann D, Misfeld M, Boning A, Tebbe U, Nowak B, Stritzke J, Laufer G, von Scheidt M; TiCAB Investigators. Ticagrelor monotherapy versus aspirin in patients undergoing multiple arterial or single arterial coronary artery bypass grafting: insights from the TiCAB trial. Eur J Cardiothorac Surg. 2020 Apr 1;57(4):732-739. doi: 10.1093/ejcts/ezz313.
Results Reference
derived
PubMed Identifier
31145798
Citation
Schunkert H, Boening A, von Scheidt M, Lanig C, Gusmini F, de Waha A, Kuna C, Fach A, Grothusen C, Oberhoffer M, Knosalla C, Walther T, Danner BC, Misfeld M, Zeymer U, Wimmer-Greinecker G, Siepe M, Grubitzsch H, Joost A, Schaefer A, Conradi L, Cremer J, Hamm C, Lange R, Radke PW, Schulz R, Laufer G, Grieshaber P, Pader P, Attmann T, Schmoeckel M, Meyer A, Ziegelhoffer T, Hambrecht R, Kastrati A, Sandner SE. Randomized trial of ticagrelor vs. aspirin in patients after coronary artery bypass grafting: the TiCAB trial. Eur Heart J. 2019 Aug 1;40(29):2432-2440. doi: 10.1093/eurheartj/ehz185.
Results Reference
derived

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

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