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One-Month DAPT in CABG Patients

RECRUITINGPhase 3Sponsored by Weill Medical College of Cornell University
Actively Recruiting
PhasePhase 3
SponsorWeill Medical College of Cornell University
Started2024-08-15
Est. completion2027-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations3 sites

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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.

Conditions2

Chronic Coronary DiseaseHeart Disease

Locations3 sites

New Jersey

1 site
Englewood Hospital
Englewood, New Jersey, 07631
Molly Schultheis, MD201-894-5670Molly.Schultheis@EHMCHealth.org

New York

2 sites
NewYork-Presbyterian: Queens Hospital
Flushing, New York, 11355
Charles A Mack, MD718-670-2400cmack@med.cornell.edu
Weill Cornell Medicine
New York, New York, 10065
Mario Gaudino, MD PhD+1 212 746 1815mfg9004@med.cornell.edu

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