Efficacy and Safety of Aspirin Therapy With CABG
A Prospective Randomized Study of the Efficacy and Safety of Aspirin Therapy With CABG
1 other identifier
interventional
350
1 country
1
Brief Summary
evaluate the safety of preoperative aspirin therapy when performing bypass surgery in conditions of artificial blood circulation
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 31, 2016
CompletedFirst Posted
Study publicly available on registry
October 24, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedOctober 24, 2016
June 1, 2016
2 years
January 31, 2016
October 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
on discharge drains after surgery in milliliters
24 hours after surgery
Secondary Outcomes (3)
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
Study Arms (2)
Experimental
EXPERIMENTALacetylsalicylic acid started for 24 hours before surgery and determination of platelet function
Control
OTHERacetylsalicylic acid stayed for 5 days before surgery and determination of platelet function
Interventions
Eligibility Criteria
You may qualify if:
- Patients 18 years of age or older
- Patient able to give informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Meshalkin State Research Institute of Circulation Pathology
Novosibirsk, 630055, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Alexander M. Chernyavskiy, MD PhD
Academician Ye. Meshalkin Novosibirsk Research Institute of Circulation Pathology Ministry of Health care of Russian Federation
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2016
First Posted
October 24, 2016
Study Start
January 1, 2016
Primary Completion
January 1, 2018
Study Completion
January 1, 2018
Last Updated
October 24, 2016
Record last verified: 2016-06
Data Sharing
- IPD Sharing
- Will not share