Ticagrelor and Aspirin for the Prevention of Cardiovascular Events After Coronary Artery Bypass Surgery (TAP-CABG)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
|Official Title:||Ticagrelor and Aspirin for the Prevention of Cardiovascular Events After Coronary Artery Bypass Surgery (CABG)|
- Composite of all-cause mortality, MI, stroke, or repeat revascularization [ Time Frame: within one year following CABG ] [ Designated as safety issue: Yes ]
- Improving graft patency [ Time Frame: 3 months post-CABG ] [ Designated as safety issue: No ]The secondary study objective is to evaluate if the combination of ticagrelor and aspirin administered after CABG will improve graft patency at 3 months, compared with aspirin alone. This will be monitored and assessing in the CT angiography substudy.
|Study Start Date:||September 2011|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Placebo twice daily. Study drug will be started within 48 hours of CABG.
Placebo 1 pill BID for 90 days
Active Comparator: ticagrelor 90 mg
Taken twice daily. Study drug will be started within 48 hours of CABG.
ticagrelor 90 mg BID for 90 days
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.
|Contact: Jackie Saw, MD, FRCPCemail@example.com|
|Canada, British Columbia|
|Vancouver General Hospital||Recruiting|
|Vancouver, British Columbia, Canada|
|Contact: Rebecca Fox, PA, MSc firstname.lastname@example.org|
|Sub-Investigator: Jian Ye|
|Sub-Investigator: Richard Cook|
|Sub-Investigator: John Mayo, MD, FRCPC|
|Sub-Investigator: John Cairns|
|Sub-Investigator: Guy Fradet|
|Sub-Investigator: John GB Mancini, MD|
|Sub-Investigator: Peter Skarsgard|
|Principal Investigator: Jackie Saw, MD, FRCPC|
|Sub-Investigator: Victoria Bernstein|
|Principal Investigator:||Jackie Saw, BSc, MD, FRCPC, FACC, FSCAI||University of British Columbia|