One-Month DAPT in CABG Patients (ODIN)

Weill Cornell Medicine (WCM)

Status and phase

Enrolling

Phase 3

Conditions

Chronic Coronary Disease

Treatments

Drug: Ticagrelor 90 MG

Drug: Low-dose aspirin

Study type

Interventional

Funder types

Other

Identifiers

NCT05997693

2023-506613-22 (EudraCT Number)

488058 (Other Grant/Funding Number)

23-06026202

Details and patient eligibility

About

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.

Full 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.

Enrollment

700 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.