Ticagrelor and Aspirin for the Prevention of Cardiovascular Events After Coronary Artery Bypass Surgery

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Subjects will be consented to the study prior to Coronary Artery Bypass Graft (CABG) and randomly assigned to receive either ticagrelor 90 mg bid or placebo bid starting within 48 hours of surgery. Subjects will remain on study drug for a minimum of 12 months during which time they will receive telephone follow-up one and nine months following CABG and clinic visits three, six, and twelve months following CABG.

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

Details

• Lead Sponsor: Cardiology Research UBC
• Collaborator: University of British Columbia
• Treatments: Aspirin; Ticagrelor

Criteria

Inclusion Criteria:

1. Males or females ≥ 19 years and ≤ 80 years old undergoing isolated CABG

2. Females of child-bearing age must have a negative pregnancy test at enrollment

Exclusion Criteria:

1. Patients undergoing combined valve or aortic surgeries

2. Patients requiring oral anticoagulant therapy on discharge that cannot be stopped (e.g. atrial fibrillation with CHADS2 score ≥ 2, pulmonary embolism, deep venous thrombosis)

3. Known allergy or intolerance to aspirin, clopidogrel or ticagrelor

4. Patients with active bleeding or history of bleeding diathesis

5. Patients with previous intracranial hemorrhage at any time, or ischemic stroke within 14 days

6. Patients with severe liver disease (e.g. ascites or signs of coagulopathy)

7. Patients with pre-operative or persistent post-operative Type 2 second-degree AV block, or 3rd degree AV block, without a permanent pacemaker

8. Patients with end-stage renal failure requiring dialysis

9. For patients enrolled in the CT angiography substudy, renal dysfunction with eGFR < 50 ml/min is an exclusion criteria