Efficacy and Safety of Aspirin Therapy With CABG

Meshalkin Research Institute of Pathology of Circulation

Status and phase: Unknown; Phase 3

Conditions: Coronary Heart Disease

Treatments: Drug: acetylsalicylic acid started for 24 hours before surgery; Drug: acetylsalicylic acid stayed for 5 days before surgery

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02942680

1184

Details and patient eligibility

About

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

Full 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

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

350 participants in 2 patient groups

Experimental

Experimental group

Description:

acetylsalicylic acid started for 24 hours before surgery and determination of platelet function

Treatment:

Drug: acetylsalicylic acid started for 24 hours before surgery

Control

Other group

Description:

acetylsalicylic acid stayed for 5 days before surgery and determination of platelet function

Treatment:

Drug: acetylsalicylic acid stayed for 5 days before surgery