NCT01373411

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Cardiology Research UBC · Academic / Other
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	ticagrelor	ticagrelor 90 mg BID for 90 days
DRUG	Placebo	Placebo 1 pill BID for 90 days

Timeline

• Start date: 2011-09-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2011-06-15
• Last updated: 2015-03-26

Locations

1 site across 1 country: Canada