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

Phase 4

• Conditions: Coronary Artery Disease; Aspirin
• Interventions: Drug: vitamin C; Drug: Aspirin

• Registration Number: NCT03049085
• Lead Sponsor: Medinet Heart Centre

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-02
• Study Start: 2017-02-01
• Study First Submitted: 2017-02-02
• Study First Submitted QC: 2017-02-07
• Last Update Submitted: 2017-02-07
• Study First Posted: 2017-02-09
• Last Update Posted: 2017-02-09
• Primary Completion: 2018-05
• Study Completion: 2019-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	vitamin C	75 mg Vit. C is administered 2 hours prior OPCAB
Aspirin group	Aspirin	a 75 mg uncoated aspirin is administered 2 hours prior to OPCAB

Primary Outcome Measures

Name	Time	Method
Myocardial Injury	72 hours following OPCAB	Myocardial injury detected by CK-MB (U/l)
Inflammation	72 hours following OPCAB	Inflammation detected by CRP (mg/l)
Kidney Injury	72 hours following OPCAB	Kidney injury detected by creatinine (mg/dl)
All-cause mortality or MACE up to 30 days after surgery	30 days after surgery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Medinet Heart Centre; 🇵🇱 Nowa Sol, Lubuskie, Poland