RECRUITING

One-Month DAPT in CABG Patients

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

One Month Dual Antiplatelet Therapy With Ticagrelor in Coronary Artery Bypass Graft Patients

Quick Facts

Study Start:2024-08-15

Study Completion:2031-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05997693

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Trisha Ali-Shaw

CONTACT

646-962-8281

tra2002@med.cornell.edu

Madeleine Wood

CONTACT

maw2069@med.cornell.edu

Principal Investigator

Marc Ruel, MD, MPH

PRINCIPAL_INVESTIGATOR

Ottawa Heart Institute Research Corporation

Mario Gaudino, MD, PhD, MSCE

PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Study Locations (Sites)

Weill Cornell Medicine

New York, New York, 10065

United States

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

Marc Ruel, MD, MPH, PRINCIPAL_INVESTIGATOR, Ottawa Heart Institute Research Corporation
Mario Gaudino, MD, PhD, MSCE, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-15

Study Completion Date2031-01

Study Record Updates

Study Start Date2024-08-15

Study Completion Date2031-01

Terms related to this study

Additional Relevant MeSH Terms

Chronic Coronary Disease