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Efficacy and Safety of Aspirin Therapy With CABG

Primary Purpose

Coronary Heart Disease

Status

Unknown status

Phase

Phase 3

Locations

Russian Federation

Study Type

Interventional

Intervention

acetylsalicylic acid started for 24 hours before surgery

acetylsalicylic acid stayed for 5 days before surgery

About this trial

This is an interventional treatment trial for Coronary Heart Disease focused on measuring coronary artery bypass grafting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Meshalkin State Research Institute of Circulation PathologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

on discharge drains after surgery in milliliters

Secondary Outcome Measures

myocardial infarction

ischemic stroke

repeat revascularization

Full Information

NCT ID

NCT02942680

First Posted

January 31, 2016

Last Updated

October 21, 2016

Sponsor

Meshalkin Research Institute of Pathology of Circulation

1. Study Identification

Unique Protocol Identification Number

NCT02942680

Brief Title

Efficacy and Safety of Aspirin Therapy With CABG

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Unknown status

Study Start Date

January 2016 (undefined)

Primary Completion Date

January 2018 (Anticipated)

Study Completion Date

January 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Meshalkin Research Institute of Pathology of Circulation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Heart Disease

Keywords

coronary artery bypass grafting

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental

Arm Type

Experimental

Arm Description

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

Arm Title

Control

Arm Type

Other

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

acetylsalicylic acid started for 24 hours before surgery

Intervention Type

Drug

Intervention Name(s)

acetylsalicylic acid stayed for 5 days before surgery

Primary Outcome Measure Information:

Title

on discharge drains after surgery in milliliters

Time Frame

24 hours after surgery

Secondary Outcome Measure Information:

Title

myocardial infarction

Time Frame

myocardial infarction by 30th day after procedure

Title

ischemic stroke

Time Frame

stroke by 30th day after procedure

Title

repeat revascularization

Time Frame

repeat revascularization within 30 days after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Aleksey Kurguzov

Phone

+9137011917

Aleksey_kurguzov@mail.ru

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexander M. Chernyavskiy, MD PhD

Organizational Affiliation

Academician Ye. Meshalkin Novosibirsk Research Institute of Circulation Pathology Ministry of Health care of Russian Federation

Official's Role

Study Chair

Facility Information:

Facility Name

Meshalkin State Research Institute of Circulation Pathology

City

Novosibirsk

ZIP/Postal Code

630055

Country

Russian Federation

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Aleksey kurguzov

Phone

+79137011917

aleksey_kurguzov@mail.ru

12. IPD Sharing Statement

Plan to Share IPD

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Efficacy and Safety of Aspirin Therapy With CABG

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