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The Effects of Preoperative Aspirin on Graft Patency and Cardiac Events in Off-pump Coronary Artery Bypass

Primary Purpose

Coronary Artery Disease, Off-pump Coronary Artery Bypass, Aspirin

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
aspirin
aspirin
Sponsored by
Chinese Academy of Medical Sciences, Fuwai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring coronary artery disease, off-pump coronary artery bypass, aspirin

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing elective, off-pump coronary artery bypass with at least two grafts
  • patient able to give informed consent

Exclusion Criteria:

  • on-pump CABG
  • combined with the valve surgery
  • Preoperative use of clopidogrel and warfarin
  • allergy to aspirin
  • History of severe liver disease
  • History of bleeding diathesis,significant GI bleed
  • Patient has known renal failure or contraindication for Cardiac CT Angio
  • Redo CABG

Sites / Locations

  • Fuwai HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

preoperative aspirin use

preoperative aspirin nonuse

Arm Description

Outcomes

Primary Outcome Measures

graft patency examined by CT scan
we would like to compare the graft patency within the one week after the surgery between the preoperative aspirin use and preoperative nonuse.We just want to know wether preoperative aspirin use could improve the graft patency in off-pump coronary artery bypass.

Secondary Outcome Measures

Bleeding, transfusion, re-exploration

Full Information

First Posted
December 29, 2010
Last Updated
December 30, 2010
Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01268917
Brief Title
The Effects of Preoperative Aspirin on Graft Patency and Cardiac Events in Off-pump Coronary Artery Bypass
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
March 2011 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Antiplatelet therapy is critical in the management of coronary artery disease.For patients undergoing off-pump coronary artery bypass graft,controversy remains regarding the safety of preoperative antiplatelet therapy.And there is little study about the effect of continuing aspirin until the surgery day on graft patency.So we would like to perform this study to evaluate the effects of preoperative aspirin on graft patency and cardiac events in off-pump coronary bypass.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Off-pump Coronary Artery Bypass, Aspirin
Keywords
coronary artery disease, off-pump coronary artery bypass, aspirin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
preoperative aspirin use
Arm Type
Experimental
Arm Title
preoperative aspirin nonuse
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
aspirin
Intervention Description
aspirin 100mg daily until the surgery day
Intervention Type
Drug
Intervention Name(s)
aspirin
Intervention Description
aspirin is stopped 5-7 days before operation
Primary Outcome Measure Information:
Title
graft patency examined by CT scan
Description
we would like to compare the graft patency within the one week after the surgery between the preoperative aspirin use and preoperative nonuse.We just want to know wether preoperative aspirin use could improve the graft patency in off-pump coronary artery bypass.
Time Frame
one week after surgery
Secondary Outcome Measure Information:
Title
Bleeding, transfusion, re-exploration
Time Frame
perioperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing elective, off-pump coronary artery bypass with at least two grafts patient able to give informed consent Exclusion Criteria: on-pump CABG combined with the valve surgery Preoperative use of clopidogrel and warfarin allergy to aspirin History of severe liver disease History of bleeding diathesis,significant GI bleed Patient has known renal failure or contraindication for Cardiac CT Angio Redo CABG
Facility Information:
Facility Name
Fuwai Hospital
City
Beijing
ZIP/Postal Code
100037
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hengchao Wu, MD
Phone
8601088398701
Email
whcwuhengchao@163.com
First Name & Middle Initial & Last Name & Degree
Hansong Sun, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
31772605
Citation
Chen S, Wu H, Yang T, Li B, Hu Y, Sun H. Does Early Graft Patency Benefit from Perioperative Statin Therapy? A Propensity Score-Matched Study of Patients Undergoing Off-Pump Coronary Artery Bypass Surgery. Cardiovasc Ther. 2019 Aug 6;2019:1582183. doi: 10.1155/2019/1582183. eCollection 2019.
Results Reference
derived

Learn more about this trial

The Effects of Preoperative Aspirin on Graft Patency and Cardiac Events in Off-pump Coronary Artery Bypass

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