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

NCT01755520 | Terminated Phase 3 DMC

• 2 other identifiers: GE IDE No. D001122012-003630-16
• Study Type: interventional
• Target: 1,893
• Locations: 3 countries
• Sites: 29

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.

Conditions

Coronary Artery Disease; Stable Angina; Acute Coronary Syndrome

Keywords

CABG; CAD; antiplatelet drug; Ticagrelor; Aspirin

Outcome Measures

Primary Outcomes (1)

• MACCE

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

  at 12 months after coronary artery bypass surgery

Secondary Outcomes (6)

• Cardiovascular death

  at 12 months after coronary artery bypass surgery

• Major bleeding events

  within 12 months after coronary arerty bypass surgery

• All cause death

  at 12 months after coronary artery bypass surgery

• Myocardial Infarction

  at 12 months after coronary artery bypass surgery

• Target Lesion Revascularization

  at 12 months after coronary artery bypass surgery

Study Arms (2)

Ticagrelor

EXPERIMENTAL

Intervention: Drug: Ticagrelor verum + Aspirin placebo

Drug: Ticagrelor; Drug: Placebo - Aspirin

Aspirin

ACTIVE COMPARATOR

Intervention: Drug: Aspirin verum + Ticagrelor placebo

Drug: Aspirin; Drug: Placebo - Ticagrelor

Interventions

Ticagrelor DRUG

90mg twice daily dose

Also known as: Brilique

Ticagrelor

Aspirin DRUG

Aspirin 100mg once daily

Also known as: ASS

Aspirin

Placebo - Ticagrelor DRUG

Placebo

Also known as: Placebo

Aspirin

Placebo - Aspirin DRUG

Placebo

Also known as: Placebo

Ticagrelor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%)

You may not qualify if:

• 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

Sponsors & Collaborators

• Deutsches Herzzentrum Muenchen: lead
• AstraZeneca: collaborator

Study Sites (29)

Medizinische Universität Wien

Vienna, 1090, Austria

Location

Klinikum Wels-Grieskirchen

Wels, 4600, Austria

Location

Deutsches Herzzentrum München

Munich, Bavaria, 80636, Germany

Location

Herzzentrum Brandenburg in Bernau

Bernau bei Berlin, Brandenburg, 16321, Germany

Location

Herz- und Kreislaufzentrum Rothenburg an der Fulda

Rotenburg an der Fulda, Hesse, 36199, Germany

Location

Universitätsklinikum Jena

Jena, Thuringia, 07747, Germany

Location

Universitätsklinikum Aachen

Aachen, 52074, Germany

Location

Herz- und Gefäßzentrum

Bad Bevensen, 29549, Germany

Location

Kerckhoff-Klinik GmbH

Bad Nauheim, 61231, Germany

Location

Charité Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Deutsches Herzzentrum Berlin

Berlin, 13353, Germany

Location

Gesundheit Nord gGmbH, Klinikum Links der Weser gGmbH

Bremen, 28277, Germany

Location

Sana Herzzentrum Cottbus GmbH

Cottbus, 03048, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, 40225, Germany

Location

Universitätsklinikum Erlangen

Erlangen, 91054, Germany

Location

St. Antonius Hospital

Eschweiler, 52249, Germany

Location

Universitäts-Herzzentrum Freiburg / Bad Krozingen

Freiburg im Breisgau, 79106, Germany

Location

Universitätsklinikum Gießen

Giessen, 35392, Germany

Location

Universitätsmedizin Göttingen

Göttingen, 37075, Germany

Location

Asklepios Klinik St.Georg

Hamburg, 20099, Germany

Location

Universitäres Herzzentrum Hamburg GmbH

Hamburg, 20299, Germany

Location

Universitätsklinikum Schleswig-Holstein, Campus Kiel

Kiel, 24105, Germany

Location

Herzzentrum Leipzig GmbH

Leipzig, 04289, Germany

Location

Klinikum Ludwigshafen

Ludwigshafen, 67063, Germany

Location

Universitätsklinikum Schleswig-Holstein, Campus Lübeck

Lübeck, 23538, Germany

Location

Kliniken Maria Hilf GmbH

Mönchengladbach, 41063, Germany

Location

Klinikum Nürnberg Süd

Nuremberg, 90419, Germany

Location

Krankenhaus der Barmherzigen Brüder Trier

Trier, 54292, Germany

Location

Schweizer Herz- und Gefässchirurgie

Bern, 3010, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 31750899 DERIVED

• 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.

  PMID: 31145798 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Angina, Stable; Acute Coronary Syndrome

Interventions

Ticagrelor; Aspirin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Heribert Schunkert, MD

  Deutsches Herzzentrum Munich Germany

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2012
• First Posted: December 24, 2012
• Study Start: April 24, 2013
• Primary Completion: May 19, 2018
• Study Completion: May 19, 2018
• Last Updated: August 2, 2018

Record last verified: 2018-08

Locations

CH (1); AU (2); DE (26)