Efficacy and Safety of Aspirin Therapy With CABG

Coronary Heart Disease Clinical Trial

Official title:

A Prospective Randomized Study of the Efficacy and Safety of Aspirin Therapy With CABG

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02942680
• Other study ID #: 1184
• Status: Recruiting
• Phase: Phase 3
• First received: January 31, 2016
• Last updated: October 21, 2016
• Start date: January 2016
• Est. completion date: January 2018

Study information

• Verified date: June 2016
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: Aleksey Kurguzov
• Phone: +9137011917
• Email: Aleksey_kurguzov[@]mail.ru
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

• ?atient 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Drug:
• acetylsalicylic acid started for 24 hours before surgery

• acetylsalicylic acid stayed for 5 days before surgery

Locations

Country	Name	City	State
Russian Federation	Meshalkin State Research Institute of Circulation Pathology	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	on discharge drains after surgery in milliliters		24 hours after surgery	Yes
Secondary	myocardial infarction		myocardial infarction by 30th day after procedure	Yes
Secondary	ischemic stroke		stroke by 30th day after procedure	Yes
Secondary	repeat revascularization		repeat revascularization within 30 days after surgery	Yes