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

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 2018

Interventions

  • Drug: Aspirin
    • preoperative uncoated 75 mg Aspirin is administered 2 hours prior OPCAB
  • Drug: vitamin C
    • preoperative 75 mg Vit. C (Placebo) is administered 2 hours prior OPCAB

Arms, Groups and Cohorts

  • Active Comparator: Aspirin group
    • a 75 mg uncoated aspirin is administered 2 hours prior to OPCAB
  • Placebo Comparator: Placebo group
    • 75 mg Vit. C is administered 2 hours prior OPCAB

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Postoperative drainage (ml)
    • Time Frame: 12 hours and 24 hours following OPCAB
  • Bleeding complication
    • Time Frame: < 30 days following OPCAB
    • reoperation for bleeding, cardiac tamponade
  • Blood transfusions (units)
    • Time Frame: < 30 days following OPCAB

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medinet Heart Centre
  • Provider of Information About this Clinical Study
    • Sponsor

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