One-Month DAPT in CABG Patients (NCT05997693) | Clinical Trial Compass
RecruitingPhase 3
One-Month DAPT in CABG Patients
United States, Austria700 participantsStarted 2024-08-15
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 includi…
What they're measuring
1
Hierarchical composite of time to death, stroke, myocardial infarction, repeat revascularization and any graft failure.
Timeframe: 1 year
Trial details
NCT IDNCT05997693
SponsorWeill Medical College of Cornell University