Ticagrelor Antiplatelet Therapy to Reduce Graft Events and Thrombosis

• Status: Active, not recruiting
• Trial end date: 2021-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Saphenous vein graft disease remains an unresolved medical problem. Many vein grafts occlude in the first year after bypass surgery, leading to adverse cardiovascular outcomes, including recurrent angina, myocardial infarction, and the need for repeat coronary intervention. While aspirin is the standard antiplatelet treatment after CABG surgery, 10-20% of vein grafts continue to occlude despite contemporary secondary preventative therapy. Compared to aspirin and other antiplatelet therapies like clopidogrel, ticagrelor treatment leads to a more pronounced platelet inhibition, and may substantially improve graft patency following CABG compared to aspirin. No data has yet to be collected regarding the impact of ticagrelor on saphenous vein graft patency following CABG. In this context, the investigators seek to compare vein graft patency between patients randomized to receive aspirin therapy, the current standard of care, or ticagrelor treatment, starting in the early postoperative period, and continuing for 2 years after CABG.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boca Raton Regional Hospital
• Collaborators: AstraZeneca; Ottawa Heart Institute Research Corporation
• Treatments: Aspirin; Ticagrelor

Criteria

Inclusion Criteria:

1. Provision of informed consent prior to any study specific procedures

2. Female and/or male patients aged 18-90 years

3. Patients undergoing first-time CABG with at least 1 saphenous vein graft, irrespective of concurrent valve surgery

Exclusion Criteria:

1. Inability to provide informed consent

2. Pregnancy or seeking pregnancy

3. Patients undergoing redo-CABG

4. Serum creatinine >1.8 mg/dL (need for contrast with CT coronary angiogram)

5. Hypersensitivity or allergy to aspirin or ticagrelor

6. Anticipated need for postoperative anticoagulation with coumadin, dabigatran or rivaroxaban (mechanical valve, chronic atrial fibrillation, DVT/PE)

7. History of gastrointestinal hemorrhage

8. Active pathological bleeding

9. History of intracranial hemorrhage

10. Severe hepatic impairment

11. Current or anticipated use of strong CYP3A4 inhibitors (e.g. ketoconazole, clarithromycin, nefazadone, ritonavir, and atazanavir)