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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03049085
• Other study ID #: Preoperative aspirin-OPCAB
• Status: Active, not recruiting
• Phase: Phase 4
• First received: February 2, 2017
• Last updated: February 7, 2017
• Start date: February 1, 2017
• Est. completion date: May 2019

Study information

• Verified date: February 2017
• Source: Medinet Heart Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: May 2019
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aspirin
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Poland	Medinet Heart Centre	Nowa Sol	Lubuskie

Sponsors (1)

Lead Sponsor	Collaborator
Medinet Heart Centre

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial Injury	Myocardial injury detected by Troponin T (ng/ml)	6 hours following OPCAB
Primary	Myocardial Injury	Myocardial injury detected by Troponin T (ng/ml)	12 hours following OPCAB
Primary	Myocardial Injury	Myocardial injury detected by Troponin T (ng/ml)	24 hours following OPCAB
Primary	Myocardial Injury	Myocardial injury detected by Troponin T (ng/ml)	72 hours following OPCAB
Primary	Inflammation	Inflammation detected by CRP (mg/l)	6 hours following OPCAB
Primary	Inflammation	Inflammation detected by CRP (mg/l)	12 hours following OPCAB
Primary	Inflammation	Inflammation detected by CRP (mg/l)	24 hours following OPCAB
Primary	Inflammation	Inflammation detected by CRP (mg/l)	72 hours following OPCAB
Primary	Kidney Injury	Kidney injury detected by creatinine (mg/dl)	6 hours following OPCAB
Primary	Kidney Injury	Kidney injury detected by creatinine (mg/dl)	12 hours following OPCAB
Primary	Kidney Injury	Kidney injury detected by creatinine (mg/dl)	24 hours following OPCAB
Primary	Kidney Injury	Kidney injury detected by creatinine (mg/dl)	72 hours following OPCAB
Primary	All-cause mortality or MACE up to 30 days after surgery		30 days after surgery
Primary	Myocardial Injury	Myocardial injury detected by CK-MB (U/l)	6 hours following OPCAB
Primary	Myocardial Injury	Myocardial injury detected by CK-MB (U/l)	12 hours following OPCAB
Primary	Myocardial Injury	Myocardial injury detected by CK-MB (U/l)	24 hours following OPCAB
Primary	Myocardial Injury	Myocardial injury detected by CK-MB (U/l)	72 hours following OPCAB
Secondary	Postoperative drainage (ml)		12 hours and 24 hours following OPCAB
Secondary	Bleeding complication	reoperation for bleeding, cardiac tamponade	< 30 days following OPCAB
Secondary	Blood transfusions (units)		< 30 days following OPCAB