Effect of Preoperative Aspirin in Patients Undergoing Off-pump Coronary Artery Bypass Grafting

Study Overview
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Brief Summary
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Effect of Preoperative Aspirin in patients undergoing Off-pump Coronary Artery Bypass Grafting. A double-blind, placebo-controlled, randomized trial.

Official Title
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Effect of Preoperative Aspirin in Patients Undergoing Off-pump Coronary Artery Bypass Grafting: A Double-blind, Placebo-controlled, Randomized Trial

Conditions
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Coronary Artery Disease, Aspirin

Intervention / Treatment
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* Drug: Aspirin
* Drug: vitamin C


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible patients undergoing off-pump coronary artery bypass grafting (OPCAB) Patients in whom antiplatelet therapy was stopped 5-7 days prior to OPCAB Exclusion Criteria: Patients undergoing on-pump coronary artery bypass grafting Patients in whom antiplatelet therapy was not stopped 5-7 days prior to OPCAB Intraoperative conversion to on-pump coronary artery bypass grafting Patients with inherited blood-clotting disorders Patients undergoing other cardiac operations

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aspirin group<br>a 75 mg uncoated aspirin is administered 2 hours prior to OPCAB | Drug: Aspirin<br>* preoperative uncoated 75 mg Aspirin is administered 2 hours prior OPCAB<br>* Other names: Acetylsalicylic acid;|
| Placebo Comparator: Placebo group<br>75 mg Vit. C is administered 2 hours prior OPCAB | Drug: vitamin C<br>* preoperative 75 mg Vit. C (Placebo) is administered 2 hours prior OPCAB<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial Injury | Myocardial injury detected by Troponin T (ng/ml) | 6 hours following OPCAB | 
| Myocardial Injury | Myocardial injury detected by Troponin T (ng/ml) | 12 hours following OPCAB | 
| Myocardial Injury | Myocardial injury detected by Troponin T (ng/ml) | 24 hours following OPCAB | 
| Myocardial Injury | Myocardial injury detected by Troponin T (ng/ml) | 72 hours following OPCAB | 
| Inflammation | Inflammation detected by CRP (mg/l) | 6 hours following OPCAB | 
| Inflammation | Inflammation detected by CRP (mg/l) | 12 hours following OPCAB | 
| Inflammation | Inflammation detected by CRP (mg/l) | 24 hours following OPCAB | 
| Inflammation | Inflammation detected by CRP (mg/l) | 72 hours following OPCAB | 
| Kidney Injury | Kidney injury detected by creatinine (mg/dl) | 6 hours following OPCAB | 
| Kidney Injury | Kidney injury detected by creatinine (mg/dl) | 12 hours following OPCAB | 
| Kidney Injury | Kidney injury detected by creatinine (mg/dl) | 24 hours following OPCAB | 
| Kidney Injury | Kidney injury detected by creatinine (mg/dl) | 72 hours following OPCAB | 
| All-cause mortality or MACE up to 30 days after surgery |  | 30 days after surgery | 
| Myocardial Injury | Myocardial injury detected by CK-MB (U/l) | 6 hours following OPCAB | 
| Myocardial Injury | Myocardial injury detected by CK-MB (U/l) | 12 hours following OPCAB | 
| Myocardial Injury | Myocardial injury detected by CK-MB (U/l) | 24 hours following OPCAB | 
| Myocardial Injury | Myocardial injury detected by CK-MB (U/l) | 72 hours following OPCAB | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative drainage (ml) |  | 12 hours and 24 hours following OPCAB | 
| Bleeding complication | reoperation for bleeding, cardiac tamponade | < 30 days following OPCAB | 
| Blood transfusions (units) |  | < 30 days following OPCAB | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ASA, OPCAB, Aspirin