Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00330772
Status:
COMPLETED
Last Update Posted:
2017-08-03
First Post:
2006-05-26
Brief Title:
Preoperative Aspirin and Postoperative Antiplatelets in Coronary Artery Bypass Grafting The PAPA CABG Study
Sponsor:
Hamilton Health Sciences Corporation
Organization:
McMaster University
Study Overview
Official Title:
Pilot Study of Preoperative Aspirin and Postoperative Clopidogrels Effects on Graft Patency and Cardiac Events in Coronary Artery Bypass Surgery
Status:
COMPLETED
Status Verified Date:
2017-08
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:
PAPA CABG
Brief Summary:
Main Research Questions
What is the effect of continuing aspirin until the time of coronary artery bypass graft surgery and of adding clopidogrel to aspirin after coronary artery bypass graft surgery for preventing blockage of coronary grafts heart attack stroke and death To reliably answer this question requires a large randomised trial Before applying for a major grant from the Canadian Institute for Health Research to do the large study we would like to perform a small pilot study of 150 patients to demonstrate that it is feasible to recruit patients and to use a new test called CT angiography to determine whether the bypass grafts are still working or have become blocked
ii Why is this research important Coronary artery bypass surgery has made a very important contribution to improving the health and survival of patients with advanced coronary artery disease but still has many problems One in 10 patients experiences a heart attack at the time of surgery 1 in 20 experiences a heart attack stroke or death during hospitalization and 1 in 4 patients has at least 1 blocked graft within 1 year of surgery Antiplatelet drugs such as aspirin and clopidogrel are effective for preventing heart attacks strokes and deaths but aspirin is usually stopped before coronary artery bypass graft surgery because of concerns about increasing the risk of bleeding The effectiveness of the combination of clopidogrel and aspirin after surgery has not been evaluated Our pilot study will provide key information about feasibility that will help us to design and perform a large definitive study in the future
iii What is being studied We will be looking at blood flow in bypass grafts as well as the occurrence of heart attack stroke and death For safety we will be looking at bleeding transfusion and need for further surgery because of bleeding We will also perform laboratory tests of platelet function to measure and compare the effect of the study treatments to prevent blood clots from forming
What is the effect of continuing aspirin until the time of coronary artery bypass graft surgery and of adding clopidogrel to aspirin after coronary artery bypass graft surgery for preventing blockage of coronary grafts heart attack stroke and death To reliably answer this question requires a large randomised trial Before applying for a major grant from the Canadian Institute for Health Research to do the large study we would like to perform a small pilot study of 150 patients to demonstrate that it is feasible to recruit patients and to use a new test called CT angiography to determine whether the bypass grafts are still working or have become blocked
ii Why is this research important Coronary artery bypass surgery has made a very important contribution to improving the health and survival of patients with advanced coronary artery disease but still has many problems One in 10 patients experiences a heart attack at the time of surgery 1 in 20 experiences a heart attack stroke or death during hospitalization and 1 in 4 patients has at least 1 blocked graft within 1 year of surgery Antiplatelet drugs such as aspirin and clopidogrel are effective for preventing heart attacks strokes and deaths but aspirin is usually stopped before coronary artery bypass graft surgery because of concerns about increasing the risk of bleeding The effectiveness of the combination of clopidogrel and aspirin after surgery has not been evaluated Our pilot study will provide key information about feasibility that will help us to design and perform a large definitive study in the future
iii What is being studied We will be looking at blood flow in bypass grafts as well as the occurrence of heart attack stroke and death For safety we will be looking at bleeding transfusion and need for further surgery because of bleeding We will also perform laboratory tests of platelet function to measure and compare the effect of the study treatments to prevent blood clots from forming
Detailed Description:
BACKGROUND Platelets play a central role in the pathogenesis of ischemic complications coronary artery bypass graft occlusion myocardial infarction stroke following CABG surgery Aspirin and clopidogrel used alone or in combination are effective for preventing ischemic complications in a broad range of high risk patients However aspirin is usually discontinued before CABG surgery because of concerns about bleeding while the combination of aspirin and clopidogrel has not been evaluated for preventing ischemic complications after CABG surgery
OBJECTIVES The overall objectives of our research are to compare the effectiveness and safety of aspirin vs placebo before bypass surgery and clopidogrel plus aspirin vs aspirin alone after surgery on
1 blockage of coronary artery bypass grafts MI stroke or death at 30 days
2 bleeding and need for transfusion after surgery The specific objective of the present pilot study is to demonstrate the feasibility of recruiting patients undergoing CABG surgery into this study and of performing CT angiography at 30 days to determine graft patency We will also measure the effect of different antiplatelet treatments on platelet function and blood markers of systemic inflammation during the first 48 hours after surgery
DESIGN This is a 2x2 factorial study of 150 elective CABG patients who will be randomized to receive low dose aspirin 81mgd or placebo for 5 days prior to surgery and aspirin 325mg loading dose followed by 81 mgd plus clopidogrel 75 mgd versus aspirin 81 mgd and placebo post operatively
OUTCOME graft patency measured by CT angiography MI stroke death bleeding transfusion requirement need for re-exploration surgery and laboratory measures of platelet function and aspirin resistance including 11-dehydro thromboxane B2
SAMPLE SIZE This is a pilot study designed primarily to demonstrate feasibility We propose to recruit a total of 150 patients over a 12 month period 2-4 per week
OBJECTIVES The overall objectives of our research are to compare the effectiveness and safety of aspirin vs placebo before bypass surgery and clopidogrel plus aspirin vs aspirin alone after surgery on
1 blockage of coronary artery bypass grafts MI stroke or death at 30 days
2 bleeding and need for transfusion after surgery The specific objective of the present pilot study is to demonstrate the feasibility of recruiting patients undergoing CABG surgery into this study and of performing CT angiography at 30 days to determine graft patency We will also measure the effect of different antiplatelet treatments on platelet function and blood markers of systemic inflammation during the first 48 hours after surgery
DESIGN This is a 2x2 factorial study of 150 elective CABG patients who will be randomized to receive low dose aspirin 81mgd or placebo for 5 days prior to surgery and aspirin 325mg loading dose followed by 81 mgd plus clopidogrel 75 mgd versus aspirin 81 mgd and placebo post operatively
OUTCOME graft patency measured by CT angiography MI stroke death bleeding transfusion requirement need for re-exploration surgery and laboratory measures of platelet function and aspirin resistance including 11-dehydro thromboxane B2
SAMPLE SIZE This is a pilot study designed primarily to demonstrate feasibility We propose to recruit a total of 150 patients over a 12 month period 2-4 per week
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