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

December 19, 2012
June 23, 2016
April 2013
December 2019   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01755520 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study Comparing Ticagrelor With Aspirin for Prevention of Vascular Events in Patients Undergoing CABG
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Coronary Artery Disease
  • Stable Angina
  • Acute Coronary Syndrome
  • Drug: Ticagrelor
    90mg twice daily dose
    Other Name: Brilique
  • Drug: Aspirin
    Aspirin 100mg once daily
    Other Name: ASS
  • Drug: Placebo - Ticagrelor
    Placebo
    Other Name: Placebo
  • Drug: Placebo - Aspirin
    Placebo
    Other Name: Placebo
  • Experimental: Ticagrelor
    Intervention: Drug: Ticagrelor verum + Aspirin placebo
    Interventions:
    • Drug: Ticagrelor
    • Drug: Placebo - Aspirin
  • Active Comparator: Aspirin
    Intervention: Drug: Aspirin verum + Ticagrelor placebo
    Interventions:
    • Drug: Aspirin
    • Drug: Placebo - Ticagrelor
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3850
April 2020
December 2019   (final data collection date for primary outcome measure)

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.
Both
18 Years and older   (Adult, Senior)
No
Contact: Heribert Schunkert, MD 00498912184073 schunkert@dhm.mhn.de
Contact: ISAResearch Center 00498912181529 dobler@dhm.mhn.de
Austria,   Germany,   Switzerland
 
NCT01755520
GE IDE No. D00112, 2012-003630-16
Yes
Undecided
Not Provided
Deutsches Herzzentrum Muenchen
Deutsches Herzzentrum Muenchen
AstraZeneca
Study Chair: Heribert Schunkert, MD Deutsches Herzzentrum Munich Germany
Deutsches Herzzentrum Muenchen
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP