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Recruiting NCT05997693

One-Month DAPT in CABG Patients

Phase III Interventional Chronic Coronary Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ticagrelor 90 MG, Low-dose aspirin.
Who it may be relevant to
Registry conditions: Chronic Coronary Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Austria, Canada, China, Germany +1
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

One Month Dual Antiplatelet Therapy With Ticagrelor in Coronary Artery Bypass Graft Patients

Overview

The purpose of this study is to compare the effect of ticagrelor plus low-dose aspirin versus low-dose aspirin alone in patients with chronic coronary disease undergoing coronary artery bypass grafting.

Detailed description

A multinational, randomized trial to evaluate the effect of one-month of ticagrelor plus low-dose aspirin, versus low-dose aspirin alone, on the incidence of death, myocardial infarction, stroke, repeat revascularization and graft failure in patients with chronic coronary disease undergoing coronary artery bypass grafting.

Interventions

  • Drug Ticagrelor 90 MG
    Ticagrelor 90 mg twice daily taken orally for one month
  • Drug Low-dose aspirin
    75-150 mg once daily taken orally

Primary outcome measures

  • Hierarchical composite of time to death, stroke, myocardial infarction, repeat revascularization and any graft failure. [Time frame: 1 year]
Secondary outcome measures (3)
  • Hierarchical composite of time to death, stroke, myocardial infarction, Bleeding Academic Research Consortium (BARC) type 3 bleeding, repeat revascularization and any graft failure. [Time frame: 1 year]
  • Hierarchical composite of time to death, stroke, myocardial infarction, repeat revascularization and 5-year time-averaged disease-specific (Seattle Angina Questionnaire [SAQ]-7) quality of life (QoL) score [Time frame: 5 years]
  • Hierarchical composite of time to death, stroke, myocardial infarction, BARC type 3 bleeding, repeat revascularization and 5-year time-averaged SAQ-7 QoL score. [Time frame: 5 years]

Eligibility criteria

Inclusion criteria

  • Age ≥18 years
  • Elective first-time CABG with use of ≥1 saphenous vein graft;
  • Ability to sign informed consent and comply with all study procedures, including follow-up for at least 5 years.

Exclusion criteria

  • Any indication for dual antiplatelet therapy, including
  • Acute/recent (within 1 year) ACS (NSTE-ACS or STEMI)
  • Recent PCI requiring continuation of dual antiplatelet therapy after CABG
  • Current or anticipated use of oral anticoagulation;
  • Paroxysmal, persistent or permanent atrial fibrillation;
  • Any concomitant cardiac or non-cardiac procedure;
  • Planned cardiac or non-cardiac surgery within one year;
  • Preoperative end-organ dysfunction (dialysis, moderate to severe liver failure, respiratory failure), cancer or other non-cardiac comorbidity with a life expectancy <5 years;
  • Inability to use the saphenous vein;
  • Contraindications to the use of aspirin;
  • Contraindications to the use of ticagrelor, including
  • Known hypersensitivity to ticagrelor
  • Active pathological bleeding (including, but not limited to gastrointestinal or intracranial bleeding)
  • History of intracranial hemorrhage
  • Concomitant therapy with strong CYP3A4 inhibitors (eg ketoconazole, clarithromycin, nefazodone, ritonavir, atazanavir)
  • Inability to undergo coronary computed tomographic angiography (CCTA);
  • Participating in another investigational device or drug study;
  • Women of childbearing potential
  • Any major perioperative complication including, but not limited to, stroke, TIA, MI, CABG-related bleeding (BARC type 4), sepsis.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Germany · 7 centers
  • University Hospital of Düsseldorf — Düsseldorf
  • Westdeutsches Herz- und Gefäßzentrum Essen, Universität Duisburg-Essen — Essen
  • Klinik für Herz- und Gefäßchirurgie - Universitäts-Herzzentrum Freiburg - Bad Krozingen — Freiburg im Breisgau
  • University Hospital Giessen — Giessen
  • Jena University Hospital — Jena
  • LMU Klinikum Campus Großhadern — München
  • Robert-Bosch-Krankenhaus Stuttgart — Stuttgart
Austria · 4 centers
  • Medical University Innsbruck — Innsbruck
  • Medical University Graz — Graz
  • Johannes Kepler University Linz — Linz
  • Medical University of Vienna — Vienna
China · 4 centers
  • Ruijin Hospital: Shanghai Jiao Tong University School of Medicine — Shanghai
  • Jilin Heart Hospital — Changchun
  • Beijing Anzhen Hospital — Beijing
  • Center China Fuwai Hospital — Beijing
United States · 3 centers
  • Englewood Hospital — Englewood
  • NewYork-Presbyterian: Queens Hospital — Flushing
  • Weill Cornell Medicine — New York
Sweden · 3 centers
  • Sahlgrenska University Hospital — Gothenburg
  • Sahlgrenska University Hospital Sweden — Gothenburg
  • Skåne University Hospital — Malmö
Canada · 1 center
  • University of Ottawa Heart Institute — Ottawa

Publications

  • Sandner S, Redfors B, Angiolillo DJ, Audisio K, Fremes SE, Janssen PWA, Kulik A, Mehran R, Peper J, Ruel M, Saw J, Soletti GJ, Starovoytov A, Ten Berg JM, Willemsen LM, Zhao Q, Zhu Y, Gaudino M. Association of Dual Antiplatelet Therapy With Ticagrelor With Vein Graft Failure After Coronary Artery Bypass Graft Surgery: A Systematic Review and Meta-analysis. JAMA. 2022 Aug 9;328(6):554-562. doi: 10. PMID 35943473
  • Sandner S, Gaudino M, Redfors B, Angiolillo DJ, Ben-Yehuda O, Bhatt DL, Fremes SE, Lamy A, Marano R, Mehran R, Pocock S, Rao SV, Spertus JA, Weinsaft JW, Wells G, Ruel M. One-month DAPT with ticagrelor and aspirin for patients undergoing coronary artery bypass grafting: rationale and design of the randomised, multicentre, double-blind, placebo-controlled ODIN trial. EuroIntervention. 2024 Mar 4;20 PMID 38436365

Identifiers

NCT: NCT05997693 · 23-06026202 · 2023-506613-22 · 488058

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗