Efficacy and Safety of Aspirin Therapy With CABG

Phase 3

• Conditions: Coronary Heart Disease
• Interventions: Drug: acetylsalicylic acid started for 24 hours before surgery; Drug: acetylsalicylic acid stayed for 5 days before surgery

• Registration Number: NCT02942680
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

Brief Summary

evaluate the safety of preoperative aspirin therapy when performing bypass surgery in conditions of artificial blood circulation

Detailed Description

The hypothesis of the study was that aspirin therapy started 24 hours before CABG is safe.

The effectiveness of this hypothesis will be assessed by the presence of a 30-day period after CABG myocardial infarction, ischemic stroke, repeat revascularizations

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-31
• Status Verified: 2016-06
• Study First Submitted QC: 2016-10-21
• Last Update Submitted: 2016-10-21
• Study First Posted: 2016-10-24
• Last Update Posted: 2016-10-24
• Primary Completion: 2018-01
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

• Patients 18 years of age or older
• Patient able to give informed consent

Exclusion Criteria

• Missing consent
• Urgent or emergent surgery
• Off-pump CABG
• Рatient has clear indication for anticoagulation (eg. mechanical heart valve, atrial fibrillation) or ADP receptor antagonist (eg. drug-eluting stent)
• History of bleeding diathesis, significant GI bleed, ICH, or liver failure
• Allergy to or intolerance of aspirin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	acetylsalicylic acid started for 24 hours before surgery	acetylsalicylic acid started for 24 hours before surgery and determination of platelet function
Control	acetylsalicylic acid stayed for 5 days before surgery	acetylsalicylic acid stayed for 5 days before surgery and determination of platelet function

Primary Outcome Measures

Name	Time	Method
on discharge drains after surgery in milliliters	24 hours after surgery

Secondary Outcome Measures

Name	Time	Method
myocardial infarction	myocardial infarction by 30th day after procedure
ischemic stroke	stroke by 30th day after procedure
repeat revascularization	repeat revascularization within 30 days after surgery

Trial Locations

Locations (1)

Meshalkin State Research Institute of Circulation Pathology; 🇷🇺 Novosibirsk, Russian Federation