One-Month DAPT in CABG Patients

Phase 3RecruitingNCT05997693

Weill Medical College of Cornell University700 enrolled

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

700

Conditions

Chronic Coronary Disease

Interventions

Ticagrelor 90 MGDRUG

Ticagrelor 90 mg twice daily taken orally for one month

Low-dose aspirinDRUG

75-150 mg once daily taken orally

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (22)

Englewood Hospital

Englewood, New Jersey, United States

Outcomes

Primary Outcomes

Hierarchical composite of time to death, stroke, myocardial infarction, repeat revascularization and any graft failure.

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

Time frame: 1 year

Secondary Outcomes

Hierarchical composite of time to death, stroke, myocardial infarction, Bleeding Academic Research Consortium (BARC) type 3 bleeding, repeat revascularization and any graft failure.

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

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

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

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.

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

Central Contacts

Trisha Ali-Shaw

CONTACT

646-962-8281 tra2002@med.cornell.edu

Data from ClinicalTrials.gov

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