Ignite Creation Date:
2024-05-05 @ 11:37 PM
Last Modification Date:
2024-10-26 @ 10:36 AM
Study NCT ID:
NCT01373411
Status:
COMPLETED
Last Update Posted:
2015-03-26
First Post:
2011-06-13
Brief Title:
Ticagrelor and Aspirin for the Prevention of Cardiovascular Events After Coronary Artery Bypass Surgery
Sponsor:
Cardiology Research UBC
Organization:
Cardiology Research UBC
Study Overview
Official Title:
Ticagrelor and Aspirin for the Prevention of Cardiovascular Events After Coronary Artery Bypass Surgery CABG
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TAP-CABG
Brief 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 81mgd 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 81mgd 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 SubstudyPatients in the CT angiography substudythe first 240 enrolled subjects will have a cardiac CT angiogram to evaluate bypass graft patency at 3-month follow-upGrafts 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
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 SubstudyPatients in the CT angiography substudythe first 240 enrolled subjects will have a cardiac CT angiogram to evaluate bypass graft patency at 3-month follow-upGrafts 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None