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Coronary Artery DiseasePhase 3TiCABNCT01755520

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

A Phase 3 study testing Ticagrelor and Aspirin in people with Coronary Artery Disease and Stable Angina, run by Deutsches Herzzentrum Muenchen at 29 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ticagrelor and Aspirin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,893 participants
Where
29 sitesin 3 countries
Study dates
24 Apr 2013to 19 May 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%)

Who cannot join

  • 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
Show all 21Show fewer
  • 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.

Trial locations and contacts

29 sites in 3 countries.

29 sites in 3 countries

Germany26 sites

  • Universitätsklinikum Aachen

    Aachen, 52074

  • Herz- und Gefäßzentrum

    Bad Bevensen, 29549

  • Kerckhoff-Klinik GmbH

    Bad Nauheim, 61231

  • Charité Universitätsmedizin Berlin

    Berlin, 10117

  • Deutsches Herzzentrum Berlin

    Berlin, 13353

  • Herzzentrum Brandenburg in Bernau

    Bernau bei Berlin, Brandenburg, 16321

  • Gesundheit Nord gGmbH, Klinikum Links der Weser gGmbH

    Bremen, 28277

  • Sana Herzzentrum Cottbus GmbH

    Cottbus, 03048

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225

  • Universitätsklinikum Erlangen

    Erlangen, 91054

  • St. Antonius Hospital

    Eschweiler, 52249

  • Universitäts-Herzzentrum Freiburg / Bad Krozingen

    Freiburg im Breisgau, 79106

  • Universitätsklinikum Gießen

    Giessen, 35392

  • Universitätsmedizin Göttingen

    Göttingen, 37075

  • Asklepios Klinik St.Georg

    Hamburg, 20099

  • Universitäres Herzzentrum Hamburg GmbH

    Hamburg, 20299

  • Universitätsklinikum Jena

    Jena, Thuringia, 07747

  • Universitätsklinikum Schleswig-Holstein, Campus Kiel

    Kiel, 24105

  • Herzzentrum Leipzig GmbH

    Leipzig, 04289

  • Universitätsklinikum Schleswig-Holstein, Campus Lübeck

    Lübeck, 23538

  • Klinikum Ludwigshafen

    Ludwigshafen, 67063

  • Kliniken Maria Hilf GmbH

    Mönchengladbach, 41063

  • Deutsches Herzzentrum München

    Munich, Bavaria, 80636

  • Klinikum Nürnberg Süd

    Nuremberg, 90419

  • Herz- und Kreislaufzentrum Rothenburg an der Fulda

    Rotenburg an der Fulda, Hesse, 36199

  • Krankenhaus der Barmherzigen Brüder Trier

    Trier, 54292

Other trials in Germany

Austria2 sites

  • Medizinische Universität Wien

    Vienna, 1090

  • Klinikum Wels-Grieskirchen

    Wels, 4600

Other trials in Austria

Switzerland1 site

  • Schweizer Herz- und Gefässchirurgie

    Bern, 3010

Other trials in Switzerland

About this study

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

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.

Read the 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.

Being tested
Ticagrelor, Aspirin, Placebo - Ticagrelor, Placebo - Aspirin
Keywords
CABG, CAD, antiplatelet drug, Ticagrelor, Aspirin
Medical subject headings
Coronary Artery Disease, Angina, Stable, Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TicagrelorDrug

    Also called Brilique

    90mg twice daily dose

  • AspirinDrug

    Also called ASS

    Aspirin 100mg once daily

  • Placebo - TicagrelorDrug

    Also called Placebo

    Placebo

  • Placebo - AspirinDrug

    Also called Placebo

    Placebo

Study groups in NCT01755520
Study groupRoleWhat they receive
TicagrelorExperimentalIntervention: Drug: Ticagrelor verum + Aspirin placebo
Receives: Drug: Ticagrelor; Drug: Placebo - Aspirin
AspirinActive comparatorIntervention: Drug: Aspirin verum + Ticagrelor placebo
Receives: Drug: Aspirin; Drug: Placebo - Ticagrelor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MACCE

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

    Measured: at 12 months after coronary artery bypass surgery

Secondary outcomes (6)

  1. Cardiovascular death

    Measured: at 12 months after coronary artery bypass surgery

  2. Major bleeding events

    Incidence of major bleeding events

    Measured: within 12 months after coronary arerty bypass surgery

  3. All cause death

    All cause death

    Measured: at 12 months after coronary artery bypass surgery

  4. Myocardial Infarction

    Measured: at 12 months after coronary artery bypass surgery

  5. Target Lesion Revascularization

    Measured: at 12 months after coronary artery bypass surgery

  6. Stroke

    Measured: at 12 months after coronary artery bypass surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2012 (estimated)
  2. Study start24 Apr 2013
  3. Primary completion19 May 2018
  4. Study completion19 May 2018

Why it stopped: DSMB Interim Analyses

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,893 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01755520
Sponsor's protocol ID
GE IDE No. D00112
Other IDs
2012-003630-16
Acronym
TiCAB
Status last verified
Aug 2018
First submitted
19 Dec 2012
Last updated
2 Aug 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 31750899

  • 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.

    PubMed 31145798

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ticagrelor and Aspirin in people with Coronary Artery Disease and Stable Angina, run by Deutsches Herzzentrum Muenchen at 29 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in Germany, Austria, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: DSMB Interim Analyses). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MACCE (time frame: at 12 months after coronary artery bypass surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01755520, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2018.

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