Efficacy and Safety of Aspirin Therapy With CABG

October 21, 2016 updated by: Meshalkin Research Institute of Pathology of Circulation

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

350

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Russian Federation
      • Novosibirsk, Russian Federation, 630055
        • Recruiting
        • Meshalkin State Research Institute of Circulation Pathology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
acetylsalicylic acid started for 24 hours before surgery and determination of platelet function
Drug: acetylsalicylic acid started for 24 hours before surgery
Other: Control
acetylsalicylic acid stayed for 5 days before surgery and determination of platelet function
Drug: acetylsalicylic acid stayed for 5 days before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
on discharge drains after surgery in milliliters
Time Frame: 24 hours after surgery
24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
myocardial infarction
Time Frame: myocardial infarction by 30th day after procedure
myocardial infarction by 30th day after procedure
ischemic stroke
Time Frame: stroke by 30th day after procedure
stroke by 30th day after procedure
repeat revascularization
Time Frame: repeat revascularization within 30 days after surgery
repeat revascularization within 30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Investigators

  • Study Chair: Alexander M. Chernyavskiy, MD PhD, Academician Ye. Meshalkin Novosibirsk Research Institute of Circulation Pathology Ministry of Health care of Russian Federation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

January 31, 2016

First Submitted That Met QC Criteria

October 21, 2016

First Posted (Estimate)

October 24, 2016

Study Record Updates

Last Update Posted (Estimate)

October 24, 2016

Last Update Submitted That Met QC Criteria

October 21, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1184

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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