Ticagrelor and Aspirin for the Prevention of Cardiovascular Events After Coronary Artery Bypass Surgery (TAP-CABG)

Cardiology Research UBC

Status and phase

Completed

Phase 4

Conditions

Coronary Artery Disease

Treatments

Drug: ticagrelor

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01373411

H10-01452

Details and patient eligibility

About

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.

Full description

Patients will be screened for eligibility pre-CABG, and informed consent signed before randomization. Aspirin 81mg/d will be started within 12 hours of CABG as per routine practice. Study medication will be started within 48 hours after CABG if there are no contraindications. Patients will be randomized to ticagrelor 90mg bid (no loading dose) or placebo bid for 1 year following CABG. Aspirin 81mg/d will be continued for at least 1 year post-CABG. Other cardiac medications will be at the discretion of the treating physicians as per standard practice.

Patients will be followed daily during their hospital stay. Outpatient visits will be scheduled at 3, 6 and 12 months. There will also be telephone contacts at 1 and 9 months.

CT Substudy:Patients in the CT angiography substudy(the first 240 enrolled subjects) will have a cardiac CT angiogram to evaluate bypass graft patency at 3-month follow-up.Grafts will be separately evaluated based upon the conduits used, internal mammary, radial, or saphenous vein grafts. Graft patency is defined as contrast filling of the conduit and the coronary artery beyond the anastomosis. Grafts with ≥50% stenosis will also be recorded. The location of the stenosis will also be recorded (proximal anastomosis, body of graft, or distal anastomosis). CT angiograms will be evaluated by 2 interpreters (radiologists or cardiologists) blinded to the randomized treatment, and will be reviewed by a 3rd interpreter if there are disagreements. If no consensus could be reached among the 3 interpreters, the graft will be deemed not analyzable, or be subject to invasive coronary angiography for definitive assessment if clinically indicated.

The primary efficacy endpoint is the composite of all-cause mortality, MI, stroke, or repeat revascularization within 1 year following CABG. Secondary endpoints include the individual endpoints of all-cause mortality, cardiovascular death, MI, stroke, repeat revascularization.

Enrollment

70 patients

Sex

All

Ages

19 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Males or females ≥ 19 years and ≤ 80 years old undergoing isolated CABG
Females of child-bearing age must have a negative pregnancy test at enrollment

Exclusion criteria

Patients undergoing combined valve or aortic surgeries
Patients requiring oral anticoagulant therapy on discharge that cannot be stopped (e.g. atrial fibrillation with CHADS2 score ≥ 2, pulmonary embolism, deep venous thrombosis)
Known allergy or intolerance to aspirin, clopidogrel or ticagrelor
Patients with active bleeding or history of bleeding diathesis
Patients with previous intracranial hemorrhage at any time, or ischemic stroke within 14 days
Patients with severe liver disease (e.g. ascites or signs of coagulopathy)
Patients with pre-operative or persistent post-operative Type 2 second-degree AV block, or 3rd degree AV block, without a permanent pacemaker
Patients with end-stage renal failure requiring dialysis
For patients enrolled in the CT angiography substudy, renal dysfunction with eGFR < 50 ml/min is an exclusion criteria