One-Month DAPT in CABG Patients

Phase 3

Recruiting

• Conditions: Chronic Coronary Disease
• Interventions: Drug: Ticagrelor 90 MG; Drug: Low-dose aspirin

• Registration Number: NCT05997693
• Lead Sponsor: Weill Medical College of Cornell University

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.

Study Timeline

• Study First Submitted: 2023-07-26
• Study First Submitted QC: 2023-08-11
• Study First Posted: 2023-08-18
• Study Start: 2024-08-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-11-01
• Primary Completion: 2027-01
• Study Completion: 2031-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 700

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ticagrelor 90 mg + Low-Dose Aspirin	Ticagrelor 90 MG	-
Ticagrelor 90 mg + Low-Dose Aspirin	Low-dose aspirin	-
Low-Dose Aspirin Alone	Low-dose aspirin	-

Primary Outcome Measures

Name	Time	Method
Hierarchical composite of time to death, stroke, myocardial infarction, repeat revascularization and any graft failure.	1 year	This is a composite endpoint to be compared between groups in a hierarchical order using the win ratio method. The following hierarchy is pre-specified: 1. Time to all-cause mortality; 2. Time to stroke; 3. Time to myocardial infarction; 4. Time to coronary revascularization; 5. Presence of graft failure at 12-month imaging follow-up or on unscheduled imaging prior to 12 month

Secondary Outcome Measures

Name	Time	Method
Hierarchical composite of time to death, stroke, myocardial infarction, Bleeding Academic Research Consortium (BARC) type 3 bleeding, repeat revascularization and any graft failure.	1 year	This is a composite endpoint to be compared between groups in a hierarchical order using the win ratio method. The following hierarchy is pre-specified: 1. Time to all-cause mortality; 2. Time to stroke; 3. Time to myocardial infarction; 4. Time to BARC 3 bleeding; 5. Time to coronary revascularization; 6. Presence of graft failure at 12-month imaging follow-up
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	5 years	This is a composite endpoint to be compared between groups in a hierarchical order using the win ratio method. The following hierarchy is pre-specified: 1. Time to all-cause mortality; 2. Time to stroke; 3. Time to myocardial infarction; 4. Time to coronary revascularization; 5. 5-year time-averaged disease-specific QOL (SAQ-7) score
Hierarchical composite of time to death, stroke, myocardial infarction, BARC type 3 bleeding, repeat revascularization and 5-year time-averaged SAQ-7 QoL score.	5 years	This is a composite endpoint to be compared between groups in a hierarchical order using the win ratio method. The following hierarchy is pre-specified: 1. Time to all-cause mortality; 2. Time to stroke; 3. Time to myocardial infarction; 4. Time to BARC 3 bleeding; 5. Time to coronary revascularization; 6. 5-year time-averaged disease-specific QOL (SAQ-7) score

Trial Locations

Locations (12)

Weill Cornell Medicine; 🇺🇸 New York, New York, United States

Medical University Graz; 🇦🇹 Graz, Austria

Medical University Innsbruck; 🇦🇹 Innsbruck, Austria

Johannes Kepler University Linz; 🇦🇹 Linz, Austria

Medical University of Vienna; 🇦🇹 Vienna, Austria

University of Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada

Westdeutsches Herz- und Gefäßzentrum Essen, Universität Duisburg-Essen; 🇩🇪 Essen, Germany

Klinik für Herz- und Gefäßchirurgie - Universitäts-Herzzentrum Freiburg - Bad Krozingen; 🇩🇪 Freiburg, Germany

Universitätsklinikum Giessen; 🇩🇪 Giessen, Germany

LMU Klinikum Campus Großhadern; 🇩🇪 München, Germany

Robert-Bosch-Krankenhaus Stuttgart; 🇩🇪 Stuttgart, Germany

Sahlgrenska University Hospital Sweden; 🇸🇪 Gothenburg, Sweden