Clinical trial NCT05997693: One-Month DAPT in CABG Patients
Official title: One Month Dual Antiplatelet Therapy With Ticagrelor in Coronary Artery Bypass Graft Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Chronic Coronary Disease
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2023-08-18
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Primary outcomes:
measure: Hierarchical composite of time to death, stroke, myocardial infarction, repeat revascularization and any graft failure.
timeFrame: 1 year
Secondary outcomes:
measure: Hierarchical composite of time to death, stroke, myocardial infarction, Bleeding Academic Research Consortium (BARC) type 3 bleeding, repeat revascularization and any graft failure.
timeFrame: 1 year
measure: 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
timeFrame: 5 years
measure: Hierarchical composite of time to death, stroke, myocardial infarction, BARC type 3 bleeding, repeat revascularization and 5-year time-averaged SAQ-7 QoL score.
timeFrame: 5 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: Graz
country: Austria
facility: Medical University Graz
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
city: Linz
country: Austria
facility: Johannes Kepler University Linz
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Essen
country: Germany
facility: Westdeutsches Herz- und Gefäßzentrum Essen, Universität Duisburg-Essen
city: Freiburg
country: Germany
facility: Klinik für Herz- und Gefäßchirurgie - Universitäts-Herzzentrum Freiburg - Bad Krozingen
city: Giessen
country: Germany
facility: Universitätsklinikum Giessen
city: München
country: Germany
facility: LMU Klinikum Campus Großhadern
city: Stuttgart
country: Germany
facility: Robert-Bosch-Krankenhaus Stuttgart
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital Sweden
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: Marc Ruel, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Weill Medical College of Cornell University
name: Mario Gaudino, MD, PhD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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: 10.1001/jama.2022.11966.