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

Primary Purpose

Coronary Artery Disease, Aspirin

Status
Unknown status
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Aspirin
vitamin C
Sponsored by
Medinet Heart Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Disease focused on measuring OPCAB, ASA, Aspirin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medinet Heart Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Aspirin group

Placebo group

Arm Description

a 75 mg uncoated aspirin is administered 2 hours prior to OPCAB

75 mg Vit. C is administered 2 hours prior OPCAB

Outcomes

Primary Outcome Measures

Myocardial Injury
Myocardial injury detected by Troponin T (ng/ml)
Myocardial Injury
Myocardial injury detected by Troponin T (ng/ml)
Myocardial Injury
Myocardial injury detected by Troponin T (ng/ml)
Myocardial Injury
Myocardial injury detected by Troponin T (ng/ml)
Inflammation
Inflammation detected by CRP (mg/l)
Inflammation
Inflammation detected by CRP (mg/l)
Inflammation
Inflammation detected by CRP (mg/l)
Inflammation
Inflammation detected by CRP (mg/l)
Kidney Injury
Kidney injury detected by creatinine (mg/dl)
Kidney Injury
Kidney injury detected by creatinine (mg/dl)
Kidney Injury
Kidney injury detected by creatinine (mg/dl)
Kidney Injury
Kidney injury detected by creatinine (mg/dl)
All-cause mortality or MACE up to 30 days after surgery
Myocardial Injury
Myocardial injury detected by CK-MB (U/l)
Myocardial Injury
Myocardial injury detected by CK-MB (U/l)
Myocardial Injury
Myocardial injury detected by CK-MB (U/l)
Myocardial Injury
Myocardial injury detected by CK-MB (U/l)

Secondary Outcome Measures

Postoperative drainage (ml)
Bleeding complication
reoperation for bleeding, cardiac tamponade
Blood transfusions (units)

Full Information

First Posted
February 2, 2017
Last Updated
February 7, 2017
Sponsor
Medinet Heart Centre
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1. Study Identification

Unique Protocol Identification Number
NCT03049085
Brief Title
Effect of Preoperative Aspirin in Patients Undergoing Off-pump Coronary Artery Bypass Grafting
Official Title
Effect of Preoperative Aspirin in Patients Undergoing Off-pump Coronary Artery Bypass Grafting: A Double-blind, Placebo-controlled, Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
May 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medinet Heart Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Aspirin
Keywords
OPCAB, ASA, Aspirin

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aspirin group
Arm Type
Active Comparator
Arm Description
a 75 mg uncoated aspirin is administered 2 hours prior to OPCAB
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
75 mg Vit. C is administered 2 hours prior OPCAB
Intervention Type
Drug
Intervention Name(s)
Aspirin
Other Intervention Name(s)
Acetylsalicylic acid
Intervention Description
preoperative uncoated 75 mg Aspirin is administered 2 hours prior OPCAB
Intervention Type
Drug
Intervention Name(s)
vitamin C
Intervention Description
preoperative 75 mg Vit. C (Placebo) is administered 2 hours prior OPCAB
Primary Outcome Measure Information:
Title
Myocardial Injury
Description
Myocardial injury detected by Troponin T (ng/ml)
Time Frame
6 hours following OPCAB
Title
Myocardial Injury
Description
Myocardial injury detected by Troponin T (ng/ml)
Time Frame
12 hours following OPCAB
Title
Myocardial Injury
Description
Myocardial injury detected by Troponin T (ng/ml)
Time Frame
24 hours following OPCAB
Title
Myocardial Injury
Description
Myocardial injury detected by Troponin T (ng/ml)
Time Frame
72 hours following OPCAB
Title
Inflammation
Description
Inflammation detected by CRP (mg/l)
Time Frame
6 hours following OPCAB
Title
Inflammation
Description
Inflammation detected by CRP (mg/l)
Time Frame
12 hours following OPCAB
Title
Inflammation
Description
Inflammation detected by CRP (mg/l)
Time Frame
24 hours following OPCAB
Title
Inflammation
Description
Inflammation detected by CRP (mg/l)
Time Frame
72 hours following OPCAB
Title
Kidney Injury
Description
Kidney injury detected by creatinine (mg/dl)
Time Frame
6 hours following OPCAB
Title
Kidney Injury
Description
Kidney injury detected by creatinine (mg/dl)
Time Frame
12 hours following OPCAB
Title
Kidney Injury
Description
Kidney injury detected by creatinine (mg/dl)
Time Frame
24 hours following OPCAB
Title
Kidney Injury
Description
Kidney injury detected by creatinine (mg/dl)
Time Frame
72 hours following OPCAB
Title
All-cause mortality or MACE up to 30 days after surgery
Time Frame
30 days after surgery
Title
Myocardial Injury
Description
Myocardial injury detected by CK-MB (U/l)
Time Frame
6 hours following OPCAB
Title
Myocardial Injury
Description
Myocardial injury detected by CK-MB (U/l)
Time Frame
12 hours following OPCAB
Title
Myocardial Injury
Description
Myocardial injury detected by CK-MB (U/l)
Time Frame
24 hours following OPCAB
Title
Myocardial Injury
Description
Myocardial injury detected by CK-MB (U/l)
Time Frame
72 hours following OPCAB
Secondary Outcome Measure Information:
Title
Postoperative drainage (ml)
Time Frame
12 hours and 24 hours following OPCAB
Title
Bleeding complication
Description
reoperation for bleeding, cardiac tamponade
Time Frame
< 30 days following OPCAB
Title
Blood transfusions (units)
Time Frame
< 30 days following OPCAB

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Medinet Heart Centre
City
Nowa Sol
State/Province
Lubuskie
ZIP/Postal Code
67-100
Country
Poland

12. IPD Sharing Statement

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

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